FDA 510(k) Application Details - K964235

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

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510(K) Number K964235
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI
1151 HOPE ST.
STAMFORD, CT 06907 US
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Contact UWE KORTH
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/23/1996
Decision Date 03/02/1999
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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