The following data is part of a premarket notification filed by Mesure Technology with the FDA for Digital Clinical Thermometer, Models St-833a & St-834a.
| Device ID | K981337 |
| 510k Number | K981337 |
| Device Name: | DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MESURE TECHNOLOGY 26792 VIA ALCALA Mission Viejo, CA 92691 -3432 |
| Contact | Phil Zulueta |
| Correspondent | Phil Zulueta MESURE TECHNOLOGY 26792 VIA ALCALA Mission Viejo, CA 92691 -3432 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00786511698850 | K981337 | 000 |
| 00786511367183 | K981337 | 000 |
| 00786511367169 | K981337 | 000 |
| 00786511085032 | K981337 | 000 |