Clearance Summary
ICI P AND S SERIES IR CAMERAS received FDA 510(k) clearance under submission number K073581, sponsored by Texas Infrared. 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 2008-07-11.
- Submission: K073581
- Applicant / Sponsor: Texas Infrared
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2008-07-11
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.