GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K073408
Device Name GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
9900 innovation dr.
wauwatosa, 
WI 
53226

Applicant Contact nicole landreville
Correspondent
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
9900 innovation dr.
wauwatosa, 
WI 
53226

Correspodent Contact nicole landreville
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 12/04/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No