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Withings Blood Pressure Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110872

by Withings

Identifiers

510(k) Number
K110872 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Withings Blood Pressure Monitor by Withings — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Withings

Sources (1)

  • FDA 510(k) K110872 24 fields · synced Jun 18, 2026