FDA 510(k) Application Details - K183101

Device Classification Name

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510(K) Number K183101
Device Name Zenition 50
Applicant Philips Medical Systems Nederland BV
Veenpluis 4-6
Best 5684PC NL
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Contact Sumit Kumar
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Regulation Number

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Classification Product Code OWB
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Date Received 11/07/2018
Decision Date 12/31/2018
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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