Martin, Check out http://www.fda.gov/cdrh/devadvice/dd_asist.html <http://www.fda.gov/cdrh/devadvice/dd_asist.html>
I am not aware of any emission requirements. On occasion when the 510K is submitted and reviewed the FDA will sometimes request emissions testing. If it never finds its way into hospital environment, then FCC requirements should be considered since it is no longer a medical device. Regards, Mark Schmidt [email protected] <mailto:[email protected]> Phone: (616) 257-2469 X-Rite Incorporated Grandville, Michigan 49418 USA Website - www.x-rite.com <http://www.x-rite.com> -----Original Message----- From: Martin Johnson [SMTP:[email protected]] Sent: Friday, June 25, 1999 6:42 AM To: [email protected] Subject: FDA requirements 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 have to consider the requirement (because he had to in his previous job, again not medical equipment). Its the first time i've come across it and all i can find on the subject are advisory guideline requirements, no mandatory requirements. Anybody able to shed some more light on this for me. Web sites, any info. gratefully received. Many Thanks MJ. _________________________________________________________ Do You Yahoo!? Get your free @yahoo.com address at http://mail.yahoo.com --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators). --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
