The following data is part of a premarket notification filed by Mesure Technology with the FDA for Ear Thermometer, Models St613c And St613f.
| Device ID | K011254 |
| 510k Number | K011254 |
| Device Name: | EAR THERMOMETER, MODELS ST613C AND ST613F |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MESURE TECHNOLOGY P.O. BOX 2249 Mission Viejo, CA 92690 |
| Contact | Phil Zulueta |
| Correspondent | Phil Zulueta MESURE TECHNOLOGY P.O. BOX 2249 Mission Viejo, CA 92690 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-24 |
| Decision Date | 2001-07-10 |