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FDA 510(k) Application Details - K012239
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K012239
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
HITACHI MEDICAL CORP.
660 WHITE PLAINS RD.
TARRYTOWN, NY 10591-5107 US
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Contact
WALTER WEYBURNE
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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
07/17/2001
Decision Date
08/10/2001
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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