Clearance Summary
DIGITAL CLINICAL THERMOMETER MODEL V901US received FDA 510(k) clearance under submission number K112116, sponsored by Amperor-Electronic(Sz) Co., Ltd.. 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 2011-10-04.
- Submission: K112116
- Applicant / Sponsor: Amperor-Electronic(Sz) Co., Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2011-10-04
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.