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FDA 510(k) Application Details - K123254
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K123254
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
B-K 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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2012
Decision Date
02/13/2013
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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