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510(k) K071985

GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND by General Electric Co. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2007
Date Received
July 19, 2007
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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