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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K080970
Device Name USHIFU STEPPER
Applicant
Ushifu Development Company, LLC
1450 S. Woodland Blvd.
Deland,  FL  32720
Applicant Contact MARE RYAN
Correspondent
Ushifu Development Company, LLC
1450 S. Woodland Blvd.
Deland,  FL  32720
Correspondent Contact MARE RYAN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/04/2008
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
Predetermined Change
Control Plan Authorized		 No
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