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FDA 510(k) Application Details - K152467
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K152467
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
CARESTREAM HEALTH, INC.
150 VERONA STREET
ROCHESTER, NY 14608 US
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Contact
CAROLYN L. WAGNER
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Regulation Number
892.1550
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Classification Product Code
IYN
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More FDA Info for this Product Code
Date Received
08/31/2015
Decision Date
12/09/2015
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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