DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K121983
Device Name DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA
Applicant
BENQ MEDICAL TECHNOLOGY CORPATION
7263 cronin circle
dublin, 
CA 
94568

Applicant Contact bob leiker
Correspondent
BENQ MEDICAL TECHNOLOGY CORPATION
7263 cronin circle
dublin, 
CA 
94568

Correspodent Contact bob leiker
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 07/06/2012
Decision Date 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No