The component is marked, "does not comply...?" I haven't seen that one yet.
Regards, Peter L. Tarver, PE Product Safety Manager Sanmina Homologation Services [email protected] > -----Original Message----- > From: [email protected] [mailto:[email protected]] > Sent: Wednesday, January 10, 2001 2:21 AM > > We use a class 3B component laser in one of our products. It has a FDA > accession number as a component and bears a big label stating > > "Does not comply with 21CFR Ch1, 1040.10(f). For use in a > Class 1 system only" > > So my advice is yes, FDA registration as a component is > required. At the end > of the day a Class 3B device is hazardous, and as an > importer/manufacturere of > a hazardous device, you need to show some due diligence and > consideration to > end use safety. >
