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FDA 510(k)

Scan Monitor

K-Number: K201456 · 2021-10-05

ApplicantWithings SA
Decision Date2021-10-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Scan Monitor is a medical device manufactured by Withings SA. It received FDA 510(k) clearance on 2021-10-05 under approval number K201456. 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 Scan Monitor?

Scan Monitor is a medical device that received FDA 510(k) clearance on 2021-10-05. It is manufactured by Withings SA. The 510(k) number is K201456.

When was Scan Monitor approved by the FDA?

Scan Monitor received FDA 510(k) clearance on 2021-10-05, under approval number K201456.

What company makes Scan Monitor?

Scan Monitor is manufactured by Withings SA.

What is the FDA product code for Scan Monitor?

The FDA product code for Scan Monitor 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.

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