Clearance Summary
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J received FDA 510(k) clearance under submission number K172870, sponsored by Hangzhou Hua'An Medical&Health Instruments 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 2018-02-13.
- Submission: K172870
- Applicant / Sponsor: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2018-02-13
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.