Clearance Summary
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 received FDA 510(k) clearance under submission number K210937, sponsored by Alicn Medical Shenzhen, Inc.. 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 2022-05-12.
- Submission: K210937
- Applicant / Sponsor: Alicn Medical Shenzhen, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2022-05-12
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.