GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K072797
Device Name GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
Applicant
GENERAL ELECTRIC CO.
9900 innovation drive
mail code: rp-2138
wauwatosa, 
WI 
53226

Applicant Contact allen schuh
Correspondent
GENERAL ELECTRIC CO.
9900 innovation drive
mail code: rp-2138
wauwatosa, 
WI 
53226

Correspodent Contact allen schuh
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 10/01/2007
Decision Date 10/17/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No