Clearance Summary
THERMOMETER (MADE IN CHINA) received FDA 510(k) clearance under submission number K811631, sponsored by Robert I. Chien & Assoc., 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 1981-07-20.
- Submission: K811631
- Applicant / Sponsor: Robert I. Chien & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2920
- Decision date: 1981-07-20
Classification & Regulation
This clearance is catalogued under FDA product code FLK and 21 CFR 880.2920, within the General Hospital review panel as a Class II device.