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 |