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510(k) DEN230050

Body Temperature Software (BTS) by Fitbit, LLC — Product Code QZA

DEN230050 is an FDA 510(k) premarket notification submitted by Fitbit, LLC for the device "Body Temperature Software (BTS)". The FDA issued a decision of De Novo Granted on December 15, 2023. The device falls under product code QZA (Body Temperature Sensing Software), a Class II device regulated under 21 CFR 880.2915. Fitbit, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 15, 2023
Date Received
July 17, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Body Temperature Sensing Software
Device Class
Class II
Regulation Number
880.2915
Review Panel
HO
Submission Type

Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.

Other clearances by Fitbit, LLC

  • K242967 — Loss of Pulse Detection (February 25, 2025)
  • K243778 — Body Temperature Software (BTS) (February 13, 2025)
  • K212372 — Fitbit Irregular Rhythm Notifications (April 8, 2022)
  • K200948 — Fitbit ECG App (September 11, 2020)
  • K133872 — ARIA WIFI SMART SCALE (June 2, 2014)

Other clearances for product code QZA

  • K243778 — Body Temperature Software (BTS) (February 13, 2025)

FDA data resources