FDA 510(k) Application Details - K181966

Device Classification Name

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510(K) Number K181966
Device Name SmartPerfusion
Applicant Philips Medical Systems Nederlands B.V.
Veenpluis 4-6
Best 5684PC NL
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Contact Chandrika Srinivasan
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Regulation Number

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Classification Product Code OWB
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Date Received 07/23/2018
Decision Date 08/17/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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