RE: Initial Laser Reports submitions to the CDRH-FDA?

2002-02-27 Thread Heppell, Les W
You can find the information on the FDA home page www.fda.gov/cdrh/index.html Les -Original Message- From: jsarell...@tuvam.com [mailto:jsarell...@tuvam.com] Sent: Wednesday, February 27, 2002 11:36 AM To: emc-p...@majordomo.ieee.org Subject: Initial

RE: Initial Laser Reports submitions to the CDRH-FDA?

2002-02-27 Thread OSBORN,DAVE (A-hsgAndover,ex1)
Hello Jorge, If I remember correctly you need to check 21 CFR 1040. Best regards, Dave Osborn Philips Medical Systems Cardiac and Monitoring Systems Secretary, ISO TC 121/SC3 d.g.osb...@ieee.org + 1 978 659 3178 fax +1 978 685 5624 -Original Message- From: jsarell...@tuvam.com [m

Re: Initial Laser Reports submitions to the CDRH-FDA?

2002-02-27 Thread Jon Curtis
Go to http://www.fda.gov/cdrh/radhlth/laser.html and check out the reporting guides on product reports and annual reports. Jon Curtis. jsarell...@tuvam.com wrote: Hello Group, Does anyone know what is the procedure to follow for laser report submittals to the CDRH? this is not a medical l

RE: Initial Laser Reports submitions to the CDRH-FDA?

2002-02-27 Thread John Juhasz
Jorge, Go to the following link and click on 'Lasers, Including Light Show' in the left window and you will see all the information you need to get started properly. http://www.fda.gov/cdrh/radhlth/index.html You can also contact me off-line for f