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FDA 510(k) Application Details - K140428
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K140428
Device Name
System, Imaging, Pulsed Echo, 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
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
02/19/2014
Decision Date
05/30/2014
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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