FDA 510(k)

Body Temperature Software (BTS)

K-Number: K243778 · 2025-02-13

Decision Date2025-02-13

Product CodeQZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Body Temperature Software (BTS) is the device name listed in this FDA 510(k) record. The listed applicant is Fitbit, LLC. It received FDA 510(k) clearance on 2025-02-13 under 510(k) 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. The listed applicant is Fitbit, LLC. The 510(k) number is K243778.

When did Body Temperature Software (BTS) receive FDA 510(k) clearance?

Body Temperature Software (BTS) received FDA 510(k) clearance on 2025-02-13, under 510(k) number K243778.

Who is the listed applicant for Body Temperature Software (BTS)?

The FDA 510(k) record lists Fitbit, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Body Temperature Software (BTS)?

The FDA product code for Body Temperature Software (BTS) is QZA.

Other records listing Fitbit, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242967Loss of Pulse Detection K212372Fitbit Irregular Rhythm Notifications K200948Fitbit ECG App

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.