Clearance Summary
ORTHO-THERM INFRARED SENSOR received FDA 510(k) clearance under submission number K812701, sponsored by Orthion Corp.. 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 1981-10-13.
- Submission: K812701
- Applicant / Sponsor: Orthion Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2980
- Decision date: 1981-10-13
Classification & Regulation
This clearance is catalogued under FDA product code IYM and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class III device.