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 [email protected] + 1 978 659 3178 fax +1 978 685 5624 -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Wednesday, February 27, 2002 12:36 PM To: [email protected] Subject: Initial Laser Reports submitions to the CDRH-FDA? Hello Group, Does anyone know what is the procedure to follow for laser report submittals to the CDRH? this is not a medical laser. It conforms to laser classification Class I. any comments, advice is appreciated. Regards, Jorge Sarellano TUV PRODUCT SERVICE Compliance Engineer Phone 408-919-3744 Fax 408-919-0585 Visit http://www.tuvam.com <http://www.tuvam.com> and discover the new "CEU Mark", multiple markets one solution! ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
