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FDA 510(k) Application Details - K162990
Device Classification Name
System, X-Ray, Mobile
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510(K) Number
K162990
Device Name
System, X-Ray, Mobile
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha, WI 53188 US
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Contact
Chris Paulik
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Regulation Number
892.1720
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Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
10/27/2016
Decision Date
11/15/2016
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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