SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K022567
Device Name SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
ACUSON CORP.
1220 charleston rd.
mountain view, 
CA 
94039 -7393

Original Contact jerry w tsutsumi
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 08/02/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No