Clearance Summary
Infrared Ear Thermometer received FDA 510(k) clearance under submission number K153146, sponsored by Sejoy Electronics & Instruments 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 2016-03-31.
- Submission: K153146
- Applicant / Sponsor: Sejoy Electronics & Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2016-03-31
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.