FDA 510(k) Application Details - K070792

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070792
Device Name System, Image Processing, Radiological
Applicant PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041 US
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Contact LYNN HARMER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/22/2007
Decision Date 04/06/2007
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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