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510(k) K061129

GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 by General Electric Co. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2006
Date Received
April 24, 2006
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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