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FDA 510(k) Application Details - K043147
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K043147
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041-3003 US
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Contact
LYNN T HARMER
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
11/15/2004
Decision Date
02/15/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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