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FDA 510(k) Application Details - K191884
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K191884
Device Name
System, X-Ray, Mobile
Applicant
Agfa N.V.
Septestraat 27
Mortsel B-2640 BE
Other 510(k) Applications for this Company
Contact
Wim Govaerts
Other 510(k) Applications for this Contact
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
07/15/2019
Decision Date
08/09/2019
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
N
Expedited Review
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