FDA 510(k) Application Details - K063814

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

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510(K) Number K063814
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SCHILLER AG
ALTGASSE 68
BAAR, ZG 6341 CH
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Contact RETO KUETTEL
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/22/2006
Decision Date 03/07/2007
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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