FDA 510(k) Application Details - K051368

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

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510(K) Number K051368
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SCHILLER AG
ALTGASSE 68
BAAR CH-6341 CH
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Contact MARKUS BUETLER
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 05/25/2005
Decision Date 08/09/2005
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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