FDA 510(k) Application Details - K212813

Device Classification Name

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510(K) Number K212813
Device Name Zenition 70
Applicant Philips Medical Systems Nederland BV
Veenpluis 4-6
Best 5684PC NL
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Contact Swapnil Sharadkumar Jain
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Regulation Number

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Classification Product Code OWB
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Date Received 09/03/2021
Decision Date 10/01/2021
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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