VENUE 40


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K112122
Device Name VENUE 40
Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa, 
WI 
53226

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

Correspodent Contact bryan behn
Regulation Number 892.1550
Classification Product Code
IYN  
Date Received 07/25/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No