The following data is part of a premarket notification filed by Mesure Technology with the FDA for Fast Thermometer Models St713c And St713f.
Device ID | K011585 |
510k Number | K011585 |
Device Name: | FAST THERMOMETER MODELS ST713C AND ST713F |
Classification | Thermometer, Electronic, Clinical |
Applicant | MESURE TECHNOLOGY P.O. BOX 2249 Mission Viejo, CA 92690 |
Contact | Phil Zulueta |
Correspondent | Phil Zulueta MESURE TECHNOLOGY P.O. BOX 2249 Mission Viejo, CA 92690 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-23 |
Decision Date | 2001-06-13 |