Withings BeamO (SCT02)
K-Number: K252474 · 2025-11-10
ApplicantWithings
Decision Date2025-11-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Withings BeamO (SCT02) is a medical device manufactured by Withings. It received FDA 510(k) clearance on 2025-11-10 under approval number K252474. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Withings BeamO (SCT02)?
Withings BeamO (SCT02) is a medical device that received FDA 510(k) clearance on 2025-11-10. It is manufactured by Withings. The 510(k) number is K252474.
When was Withings BeamO (SCT02) approved by the FDA?
Withings BeamO (SCT02) received FDA 510(k) clearance on 2025-11-10, under approval number K252474.
What company makes Withings BeamO (SCT02)?
Withings BeamO (SCT02) is manufactured by Withings.
What is the FDA product code for Withings BeamO (SCT02)?
The FDA product code for Withings BeamO (SCT02) is DPS.
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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.