Loss of Pulse Detection
K-Number: K242967 · 2025-02-25
ApplicantFitbit
Decision Date2025-02-25
Product CodeSDY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Loss of Pulse Detection is a medical device manufactured by Fitbit. It received FDA 510(k) clearance on 2025-02-25 under approval number K242967. The device is classified under product code SDY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Fitbit. The 510(k) number is K242967.
When was Loss of Pulse Detection approved by the FDA?
Loss of Pulse Detection received FDA 510(k) clearance on 2025-02-25, under approval number K242967.
What company makes Loss of Pulse Detection?
Loss of Pulse Detection is manufactured by Fitbit.
What is the FDA product code for Loss of Pulse Detection?
The FDA product code for Loss of Pulse Detection is SDY.
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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.