510(k) K052441

GE LOGIQ 7 ULTRASOUND BT05 by General Electric Co. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2005
Date Received
September 6, 2005
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