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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K921682
Device Name ZINETICS AMC
Applicant
Zinetics Medical, Inc.
Forty-Eight Tempest Park
2212 S. W. Temple
Salt Lake City,  UT  84115
Applicant Contact RICHARD VINCINS
Correspondent
Zinetics Medical, Inc.
Forty-Eight Tempest Park
2212 S. W. Temple
Salt Lake City,  UT  84115
Correspondent Contact RICHARD VINCINS
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/08/1992
Decision Date 12/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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