GE MARLIN ULTRASOUND

Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K033139
Device Name GE MARLIN ULTRASOUND
Applicant
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee, 
WI 
53201

Applicant Contact allen schuh
Correspondent
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee, 
WI 
53201

Correspodent Contact allen schuh
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 09/30/2003
Decision Date 10/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No