Clearance Summary
MODIFIED MYOCARDIAL TEMPERATURE SENSOR received FDA 510(k) clearance under submission number K874522, sponsored by Mon-A-Therm, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-01-29.
- Submission: K874522
- Applicant / Sponsor: Mon-A-Therm, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1915
- Decision date: 1988-01-29
Classification & Regulation
This clearance is catalogued under FDA product code KRB and 21 CFR 870.1915, within the Cardiovascular review panel as a Class II device.