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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 Doppler, Ultrasonic
510(k) Number K030191
Device Name TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
Applicant
Teratech Corp.
77-79 Terrace Hall Ave.
Burlington,  MA  01803
Applicant Contact CHARLES F HOTTINGER
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/21/2003
Decision Date 01/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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