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FDA 510(k) Application Details - K181565
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K181565
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
Biokinemetrics Inc.
211 East 4th Street
Carroll, IA 51401 US
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Contact
Steven Kraus
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Regulation Number
892.1650
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Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
06/14/2018
Decision Date
07/13/2018
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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