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FDA 510(k) Application Details - K102005
Device Classification Name
More FDA Info for this Device
510(K) Number
K102005
Device Name
ALLURA XPER OR TABLE SERIES
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
22100 BOTHELL EVERETT HWY
BOTHELL, WA 98041-3003 US
Other 510(k) Applications for this Company
Contact
LYNN HARMER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2010
Decision Date
08/09/2010
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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