Dear experts,
I was yesterday speaking with one client who is quite desperate. They are
producing medical products which contain wifi modules. They have told me, that
FDA currently does not accept any such product if no additional testing on wifi
module inside the unit are performed. The
Hello Peter,
This may be similar to the product in question:
http://www.alliedhealth.net/micro_ablation.htm
Best regards,
Ron Wellman
At 10:12 AM 4/9/2003 -0700, Peter L. Tarver wrote:
Nick -
this sounds like one of those electric skin/muscle toner
devices.
While I didn't find specific
Hello Nick,
I'd be curious as to what claims the manufacturer makes for this beauty
treatment product. That may determine one thing in regards to potential
misbranding under FDA regulations but if there are similar devices already
on the market in the USA, I would check to see how they are
I've been asked to take a look at the requirements for a beauty
treatment product which the client wants to push for the US market.
It works by passing a small current through the skin.
The client is adamant that this is not a medical device in the sense
of the EU Medical Devices requirements
...@conformityassessment.com
Tel: 978-524-9890
Fax: 978-524-9898
-Original Message-
From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org] On Behalf
Of Nick Williams
Sent: Tuesday, July 04, 2000 11:15 AM
To: emc-p...@majordomo.ieee.org
Subject:FDA requirements
Can
Hello Nick..
Try here as a starting point: http://www.fda.gov/
Good Luck ,
George
-Original Message-
From: Nick Williams [mailto:nick.willi...@conformance.co.uk]
Sent: Tuesday, July 04, 2000 11:15 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA requirements
Can somebody give me
AM
To: emc-p...@majordomo.ieee.org
Subject: FDA requirements
Can somebody give me a good pointer for resource in relation to the
US FDA requirements (i.e. what is covered, and what the requirements
are?)
I've been asked to consider what might be required for the sale of a
clinical thermometer
Can somebody give me a good pointer for resource in relation to the
US FDA requirements (i.e. what is covered, and what the requirements
are?)
I've been asked to consider what might be required for the sale of a
clinical thermometer for consumer use in the US.
Regards
Nick
Hi all,
I have been asked by a client if there are any European test houses
that can perform X-ray testing on monitors to FDA requirements. I do
not have any more specific details. Anyone able to help?
Thanks
John Fee
NETC
f...@netc.ie
, August 18, 1999 5:13 PM
To: Non-HP-emc-pstc /HP-PaloAlto,shargw3/dd.HPMEXT1=emc-p...@majordomo.ieee.org
Cc: Non-HP-feej /HP-PaloAlto,shargw3/dd.HPMEXT1=f...@netc.ie
Subject: X-Ray testing to FDA requirements
Hi all,
I have been asked by a client if there are any European test
Thanks for all your replies (espeicaly Lou, i did ask to see where it
was written but still haven't seen it yet!).
Everybody seems to have agreed with what i said to our engineer, so
hopefully he'll now go away and let me get on with my job.
Thanks
MJ
-Original Message-
From: Martin Johnson [SMTP:calpe1...@yahoo.com]
Sent: Friday, June 25, 1999 6:42 AM
To: emc-p...@ieee.org
Subject:FDA requirements
When producing equipment that uses flat screen (LCD) 1/4 VGA displays,
is there any requirement to meet FDA emission
As far as I am aware, the FDA requirements (21CFR) relate to the emission
of X-rays from CRTs within monitors. We always state that any LCD displays
within our products are therefore exempt from the FDA requirements.
I also have on file a letter to all manufacturers and importers of
television
this requirement.
--
From: Martin Johnson [SMTP:calpe1...@yahoo.com]
Sent: Friday, June 25, 1999 6:42 AM
To: emc-p...@ieee.org
Subject: FDA requirements
When producing equipment that uses flat screen (LCD) 1/4 VGA
displays,
is there any
When producing equipment that uses flat screen (LCD) 1/4 VGA displays,
is there any requirement to meet FDA emission requirements (overall
equipment is not for medical use, and would never find its way into a
hospital environment).
I only ask as one of my collegues is quite insistent that we
Does anyone know what specific FDA regulations would cover a system used in
medical imaging? It appears that it can go down to the BIOS level.
Happy Holidays
Glenn Lesmeister
glenn.lesmeis...@compaq.com mailto:glenn.lesmeis...@compaq.com
Compaq Tel: 281-514-5163
20555 SH 249,
Engineer
Eaton Corporation
ph:512 248-2851
fax: 512 248-2050
email: jbu...@aus.etn.com
-Original Message-
From: Mike Morrow [SMTP:mmor...@compuserve.com]
Sent: Thursday, August 27, 1998 8:04 AM
To: IEEE EMC Board
Subject: FDA Requirements
finishes to contact materials that are in
the 15 to 35RA range depending on application.
Regards, Jim
From: Mike Morrow mmor...@compuserve.com
Subject: FDA Requirements
Date: Thu, 27 Aug 1998 09:03:58 -0400
To: IEEE EMC Board emc-p...@ieee.org
I've always been
I've always been told that any piece of equipment being used in a
sanitary application (i.e. food processing, etc) must be constructed of
stainless steel. I'm after the actual standard that has this
requirement. Can aluminum be used??
Any help is appreciated.
Mike Morrow
Devices
--
From: Mike Morrow
To: IEEE EMC Board
Subject: FDA Requirements
List-Post: emc-pstc@listserv.ieee.org
Date: Thursday, August 27, 1998 6:03AM
I've always been told that any piece of equipment being used in a
sanitary application (i.e. food processing, etc) must be constructed
-301-855-1375
Fax:001-410-586-1460
Email: band...@resemc.com
Web;www.resemc.com
--
From: becky...@aol.com [SMTP:becky...@aol.com]
Sent: Thursday, August 13, 1998 4:32 PM
To: emc-p...@majordomo.ieee.org
Subject: FDA requirements
I am working on a machine that has electrodes
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