FDA 510(k) Application Details - K171937

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

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510(K) Number K171937
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Microlife Intellectual Property GmbH
Espenstrasse 139
Widnau 9443 CH
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Contact Gerhard Frick
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 06/28/2017
Decision Date 03/16/2018
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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