Clearance Summary
Phoenix Digital Thermometer received FDA 510(k) clearance under submission number K201032, sponsored by Phoenix Innovative Healthcare Manufacturers Pvt. , 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 2021-10-29.
- Submission: K201032
- Applicant / Sponsor: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2021-10-29
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.