510(k) K142323

Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System by Ge Medical Systems Israel , Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2014
Date Received
August 20, 2014
Clearance Type
Traditional
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