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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K190300
Device Name BIOK7600W Wireless Flat Panel Detector
Applicant
Biokinemetrics Inc.
211 East 4th Street
Carroll,  IA  51401
Applicant Contact Steven Kraus
Correspondent
Biokinemetrics Inc.
211 East 4th Street
Carroll,  IA  51401
Correspondent Contact Steven Kraus
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/12/2019
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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