Clearance Summary
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER received FDA 510(k) clearance under submission number K885187, 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 1989-03-08.
- Submission: K885187
- 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: 1989-03-08
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.