The following data is part of a premarket notification filed by Mascot, Inc. with the FDA for Mascot Thermoter.
Device ID | K903500 |
510k Number | K903500 |
Device Name: | MASCOT THERMOTER |
Classification | Thermometer, Clinical Mercury |
Applicant | MASCOT, INC. 16635 VALLEY VIEW Cerritos, CA 90701 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-03 |
Decision Date | 1990-10-09 |