FDA 510(k) Application Details - K060686

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

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510(K) Number K060686
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH
MAX SCHMIDHEINY-STRASSE 201
HEERBRUGG 9435 CH
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Contact ARIEL WANG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 03/15/2006
Decision Date 06/09/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party Y
Expedited Review



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