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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K003890
Device Name VHF ULTRASONIC ARC-SCAN SYSTEM
Applicant
Ultralink, LLC
2083 Hawaii Ave. NE
St Petersburg,  FL  33707
Applicant Contact GEORGE D WISEMAN
Correspondent
Ultralink, LLC
2083 Hawaii Ave. NE
St Petersburg,  FL  33707
Correspondent Contact GEORGE D WISEMAN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/18/2000
Decision Date 05/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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