Clearance Summary
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P received FDA 510(k) clearance under submission number K033967, sponsored by Flir Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2004-03-09.
- Submission: K033967
- Applicant / Sponsor: Flir Systems
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2004-03-09
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.