Clearance Summary
Infrared Ear Thermometer received FDA 510(k) clearance under submission number K180387, sponsored by Hetaida Technology Co., Ltd.. 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 2019-01-10.
- Submission: K180387
- Applicant / Sponsor: Hetaida Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2019-01-10
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.