SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM


codes

Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K002185
Device Name SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
MEDISON AMERICA, INC.
16303 panoramic way
san leandro, 
CA 
94578 -1116

Original Contact gary j allsebrook
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 07/19/2000
Decision Date 08/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls