FDA 510(k) Application Details - K110872

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K110872
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant WITHINGS
NO.58, FU CHIUN STREET
HSIN CHU CITY 30067 TW
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Contact JEN KE-MIN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 03/29/2011
Decision Date 05/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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