Clearance Summary
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) received FDA 510(k) clearance under submission number K122912, sponsored by Hangzhou Hua'An Medical & Health Instruments Co.,. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-11-07.
- Submission: K122912
- Applicant / Sponsor: Hangzhou Hua'An Medical & Health Instruments Co.,
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2012-11-07
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.