Clearance Summary
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER received FDA 510(k) clearance under submission number K051566, sponsored by Proton Healthcare , 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 2006-01-17.
- Submission: K051566
- Applicant / Sponsor: Proton Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2006-01-17
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.