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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Examination, Medical, Powered
510(k) Number K945163
Device Name ECHOCARDIOGRAPHY
Applicant
Tri W-G, Inc.
P.O. Box 905
Valley City,  ND  58072
Applicant Contact DAVID KESLER
Correspondent
Tri W-G, Inc.
P.O. Box 905
Valley City,  ND  58072
Correspondent Contact DAVID KESLER
Regulation Number878.4960
Classification Product Code
LGX  
Date Received10/21/1994
Decision Date 02/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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