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FDA 510(k) Application Details - K974588
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K974588
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
RIMED LTD.
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact
AHAVA STEIN
Other 510(k) Applications for this Contact
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
12/09/1997
Decision Date
08/07/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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