FDA 510(k) Application Details - K062974

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

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510(K) Number K062974
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH
13605 W. 7TH AVE.
GOLDEN, CO 80401-4604 US
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Contact ROBERT N CLARK
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/29/2006
Decision Date 08/13/2007
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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