FDA 510(k) Application Details - K151761

Device Classification Name Alarm, Blood-Pressure

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510(K) Number K151761
Device Name Alarm, Blood-Pressure
Applicant PHILLIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact Greg Li
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Regulation Number 870.1100

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Classification Product Code DSJ
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Date Received 06/29/2015
Decision Date 09/29/2015
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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