Clearance Summary
MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR received FDA 510(k) clearance under submission number K874523, sponsored by Mon-A-Therm, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-01-06.
- Submission: K874523
- Applicant / Sponsor: Mon-A-Therm, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1988-01-06
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.