The following data is part of a premarket notification filed by Proton Healthcare Ltd. with the FDA for Proton Phc 8731 10 Second Digital Thermometer; Proton Phc 109 Ear Thermometer; Proton 889 Ear Thermometer.
| Device ID | K051566 |
| 510k Number | K051566 |
| Device Name: | PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | PROTON HEALTHCARE LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls PROTON HEALTHCARE LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2006-01-17 |
| Summary: | summary |