Clearance Summary
CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT received FDA 510(k) clearance under submission number K902625, sponsored by Liaoning-Usa Corp.. 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 1990-10-26.
- Submission: K902625
- Applicant / Sponsor: Liaoning-Usa Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2920
- Decision date: 1990-10-26
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.