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FDA 510(k) Application Details - K061685
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K061685
Device Name
System, X-Ray, Mobile
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003, MS 915
BOTHELL, WA 98041-3003 US
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Contact
JOSEPH S ARNAUDO
Other 510(k) Applications for this Contact
Regulation Number
892.1720
More FDA Info for this Regulation Number
Classification Product Code
IZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2006
Decision Date
09/15/2006
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
Y
Expedited Review
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