FDA 510(k) Application Details - K120132

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

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510(K) Number K120132
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact MARY KRUITWAGEN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 01/17/2012
Decision Date 02/14/2012
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 N
Expedited Review



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