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FDA 510(k) Application Details - K142323
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K142323
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
GE MEDICAL SYSTEMS ISRAEL LTD.
4 Etgar Street
Tirat Carmel 39120 IL
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Contact
Bryan Behn
Other 510(k) Applications for this Contact
Regulation Number
892.1550
More FDA Info for this Regulation Number
Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/2014
Decision Date
10/10/2014
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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