The following data is part of a premarket notification filed by Z7 International with the FDA for Thermometer Models St8631.
| Device ID | K021048 |
| 510k Number | K021048 |
| Device Name: | THERMOMETER MODELS ST8631 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Z7 INTERNATIONAL 34138 COURTNEY TERRACE Acton, CA 93510 |
| Contact | Phil Zulueta |
| Correspondent | Phil Zulueta Z7 INTERNATIONAL 34138 COURTNEY TERRACE Acton, CA 93510 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-04-22 |