Proton Phc 8731 10 Second Digital Thermometer; Proton Phc 109 Ear Thermometer; Proton 889 Ear Thermometer
by Proton Healthcare, Ltd. 510(k)
Active
510(k) K051566
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051566 | Date17 Jan 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Models / Variants
- FDA applicant
- Proton Healthcare , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent