LOGIQ E9


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K110943
Device Name LOGIQ E9
Applicant
GE HEALTHCARE
9900 innovation drive
rp-2138
wauwatosa, 
WI 
53226

Applicant Contact bryan behn
Correspondent
GE HEALTHCARE
9900 innovation drive
rp-2138
wauwatosa, 
WI 
53226

Correspodent Contact bryan behn
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 04/04/2011
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls