FDA 510(k) Application Details - K071015

Device Classification Name System, X-Ray, Mobile

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510(K) Number K071015
Device Name System, X-Ray, Mobile
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
J-15
MALVERN, PA 19355 US
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Contact KIMBERLY RENDON
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 04/10/2007
Decision Date 05/10/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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