ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K991805
Device Name ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
Applicant
ACUSON CORP.
1220 charleston rd.
mountain view, 
CA 
94039 -7393

Applicant Contact william welch
Correspondent
ACUSON CORP.
1220 charleston rd.
mountain view, 
CA 
94039 -7393

Correspodent Contact william welch
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 05/26/1999
Decision Date 08/02/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No