USHIFU STEPPER


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K080970
Device Name USHIFU STEPPER
Applicant
USHIFU DEVELOPMENT COMPANY, LLC
1450 south woodland blvd.
deland, 
FL 
32720

Applicant Contact mare ryan
Correspondent
USHIFU DEVELOPMENT COMPANY, LLC
1450 south woodland blvd.
deland, 
FL 
32720

Correspodent Contact mare ryan
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 04/04/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No