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510(k) K133125

WITHINGS BLOOD PRESURE MONITOR by Withings — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2014
Date Received
September 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K160544 — Withings Thermo (Model SCT01) (June 17, 2016)
  • K110872 — WITHINGS BLOOD PRESSURE MONITOR (May 20, 2011)

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