DEN230050 is an FDA 510(k) submission for the Body Temperature Software (BTS). This device is classified as a Body Temperature Sensing Software (Class II - Special Controls, product code QZA).
Submitted by Fitbit, LLC (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on December 15, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2915. Body Temperature Sensing Software Is A Software Device Used For The Determination Of Human Body Temperature By Means Of Analyzing Input Sensor Data..
| 510(k) Number | DEN230050 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 17, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 151 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QZA - Body Temperature Sensing Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2915 |
| Definition | Body Temperature Sensing Software Is A Software Device Used For The Determination Of Human Body Temperature By Means Of Analyzing Input Sensor Data. |