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FDA 510(k) Application Details - K172498
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K172498
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
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/2017
Decision Date
10/13/2017
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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