FDA 510(k) Application Details - K151910

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K151910
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant BK MEDICAL APS
MILEPARKEN 34
HERLEV DK-2730 DK
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Contact Randi Hauerberg
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 07/13/2015
Decision Date 10/05/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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