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510(k) K081921

GE VIVID E9 ULTRASOUND by General Electric Co. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2008
Date Received
July 7, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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