The following data is part of a premarket notification filed by Mesure Technology with the FDA for Digital Clinical Thermometer St-813a, St-814a, St-823 And St-823a.
| Device ID | K962520 |
| 510k Number | K962520 |
| Device Name: | DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MESURE TECHNOLOGY C/O Z 7 INTL. 26792 VIA ALCALA Mission Viejo, CA 92691 |
| Contact | Phil Z Ulueta |
| Correspondent | Phil Z Ulueta MESURE TECHNOLOGY C/O Z 7 INTL. 26792 VIA ALCALA Mission Viejo, CA 92691 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-27 |
| Decision Date | 1996-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681131060278 | K962520 | 000 |
| 10767056156811 | K962520 | 000 |
| 10767056156392 | K962520 | 000 |
| 10036800396927 | K962520 | 000 |