SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM

information about

Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K002239
Device Name SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
KONTRON MEDICAL SYSTEMS SAS
377 route 17 south
hasbrouck heights, 
NJ 
07601

Original Contact george myers
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received 07/24/2000
Decision Date 08/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No