510(k) K041813

GE LOGIQ 7 ULTRASOUND BT04 by Ge Medical Systems Ultrasound and Primary Care Dia — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2004
Date Received
July 6, 2004
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