FDA 510(k) Application Details - K042368

Device Classification Name System, X-Ray, Mobile

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510(K) Number K042368
Device Name System, X-Ray, Mobile
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL, WA 98021-8431 US
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Contact LYNN HARMER
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 08/31/2004
Decision Date 10/04/2004
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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