Body Temperature Software (BTS)
K-Number: K243778 · 2025-02-13
ApplicantFitbit, LLC
Decision Date2025-02-13
Product CodeQZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Body Temperature Software (BTS) is a medical device manufactured by Fitbit, LLC. It received FDA 510(k) clearance on 2025-02-13 under approval number K243778. The device is classified under product code QZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Body Temperature Software (BTS)?
Body Temperature Software (BTS) is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Fitbit, LLC. The 510(k) number is K243778.
When was Body Temperature Software (BTS) approved by the FDA?
Body Temperature Software (BTS) received FDA 510(k) clearance on 2025-02-13, under approval number K243778.
What company makes Body Temperature Software (BTS)?
Body Temperature Software (BTS) is manufactured by Fitbit, LLC.
What is the FDA product code for Body Temperature Software (BTS)?
The FDA product code for Body Temperature Software (BTS) is QZA.
Other Devices by Fitbit, LLC
Related Devices (Code: QZA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.