FDA 510(k)

Loss of Pulse Detection

Numéro K : K242967 · 2025-02-25

DemandeurFitbit

Date de décision2025-02-25

Code produitSDY

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Loss of Pulse Detection is the device name listed in this FDA 510(k) record. The listed applicant is Fitbit. It received FDA 510(k) clearance on 2025-02-25 under 510(k) number K242967. The device is classified under product code SDY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Loss of Pulse Detection?

Loss of Pulse Detection is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is Fitbit. The 510(k) number is K242967.

When did Loss of Pulse Detection receive FDA 510(k) clearance?

Loss of Pulse Detection received FDA 510(k) clearance on 2025-02-25, under 510(k) number K242967.

Who is the listed applicant for Loss of Pulse Detection?

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

What is the FDA product code for Loss of Pulse Detection?

The FDA product code for Loss of Pulse Detection is SDY.

Essais cliniques associés

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Source officielle

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