The following data is part of a premarket notification filed by Mesure Technology with the FDA for Thermometer Models St8132c, St8132f, St8142c, St8142f, St8532c, St8532f, St8542c, And St8542f.
Device ID | K013779 |
510k Number | K013779 |
Device Name: | THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F |
Classification | Thermometer, Electronic, Clinical |
Applicant | MESURE TECHNOLOGY 34138 COURTNEY TERRACE Acton, CA 93510 |
Contact | Phil Zulueta |
Correspondent | Phil Zulueta MESURE TECHNOLOGY 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 | 2001-11-13 |
Decision Date | 2002-03-29 |