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 |