The following data is part of a premarket notification filed by Blue Spark Technologies Inc. with the FDA for Temptraq Tt-100.
| Device ID | K143267 |
| 510k Number | K143267 |
| Device Name: | TempTraq TT-100 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Blue Spark Technologies Inc. 806 Sharon Drive, Suite G Westlake, OH 44145 |
| Contact | Jennifer Cartledge |
| Correspondent | Jennifer Cartledge REU Associates Inc. 409 Woodridge Dr. Seneca, SC 29672 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851203006142 | K143267 | 000 |
| 00851203006166 | K143267 | 000 |
| 00851203006197 | K143267 | 000 |
| 00851203006272 | K143267 | 000 |
| 00851203006265 | K143267 | 000 |
| 00851203006258 | K143267 | 000 |
| 00851203006241 | K143267 | 000 |
| 00851203006234 | K143267 | 000 |
| 00851203006104 | K143267 | 000 |
| 00851203006173 | K143267 | 000 |
| 00851203006005 | K143267 | 000 |
| 00851203006012 | K143267 | 000 |
| 00851203006135 | K143267 | 000 |
| 00851203006128 | K143267 | 000 |
| 00851203006111 | K143267 | 000 |
| 00851203006074 | K143267 | 000 |
| 00851203006067 | K143267 | 000 |
| 00851203006043 | K143267 | 000 |
| 00851203006036 | K143267 | 000 |
| 00851203006029 | K143267 | 000 |
| 00851203006050 | K143267 | 000 |