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FDA 510(k) Application Details - K200917
Device Classification Name
More FDA Info for this Device
510(K) Number
K200917
Device Name
Azurion R2.1
Applicant
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best 5684PC NL
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Contact
Michelle Campbell
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Regulation Number
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Classification Product Code
OWB
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Date Received
04/06/2020
Decision Date
05/01/2020
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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