The following data is part of a premarket notification filed by Blue Spark Technologies Inc. with the FDA for Temptraq.
Device ID | K201977 |
510k Number | K201977 |
Device Name: | TempTraq |
Classification | Thermometer, Electronic, Clinical |
Applicant | Blue Spark Technologies Inc. 806 Sharon Drive, Suite G Westlake, OH 44145 |
Contact | John Gannon |
Correspondent | Rita King MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-16 |
Decision Date | 2020-12-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TEMPTRAQ 98719446 not registered Live/Pending |
Blue Spark Technologies, Inc. 2024-08-27 |
![]() TEMPTRAQ 86261189 4766108 Live/Registered |
Blue Spark Technologies, Inc. 2014-04-24 |