The following data is part of a premarket notification filed by Flir Systems with the FDA for Telethermographic Camera, Series A, E, S And P.
Device ID | K033967 |
510k Number | K033967 |
Device Name: | TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P |
Classification | System, Telethermographic (adjunctive Use) |
Applicant | FLIR SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Contact | Paul Dryden |
Correspondent | Paul Dryden FLIR SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Product Code | LHQ |
CFR Regulation Number | 884.2980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-22 |
Decision Date | 2004-03-09 |
Summary: | summary |