GE LOGIQ 9, MODEL 2188900-X


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K011188
Device Name GE LOGIQ 9, MODEL 2188900-X
Original Applicant
GE MEDICAL SYSTEMS
po box 414
milwaukee, 
WI 
53201

Original Contact allen schuh
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received 04/18/2001
Decision Date 05/18/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No