Clearance Summary
iHealth infrared Ear thermometer PT5 received FDA 510(k) clearance under submission number K212598, sponsored by Andon Health Co, Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-01-28.
- Submission: K212598
- Applicant / Sponsor: Andon Health Co, Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2022-01-28
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.