FDA 510(k) Application Details - K161839

Device Classification Name

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510(K) Number K161839
Device Name 2D Quantitative Analysis
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND BV
VEENPLUIS 4-6
BEST 5684PC NL
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Contact JEANETTE BECKER
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Regulation Number

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Classification Product Code OWB
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Date Received 07/05/2016
Decision Date 07/29/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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