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FDA 510(k) Application Details - K190461
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K190461
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best 5684 PC NL
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Contact
Jan van de Kerkhof
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
02/26/2019
Decision Date
06/04/2019
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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