K243778 is an FDA 510(k) clearance 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 Cleared decision on February 13, 2025, 66 days after receiving the submission on December 9, 2024.
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 | K243778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2024 |
| Decision Date | February 13, 2025 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |