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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 K984444
Device Name INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
Applicant
Sandhill Scientific, Inc.
8955 S. Ridgeline Blvd.,
Unit #500
Highlands Ranch,  CO  80126
Applicant Contact LINDA L DIEDERICH
Correspondent
Sandhill Scientific, Inc.
8955 S. Ridgeline Blvd.,
Unit #500
Highlands Ranch,  CO  80126
Correspondent Contact LINDA L DIEDERICH
Regulation Number876.1725
Classification Product Code
FFX  
Subsequent Product Code
KLA  
Date Received12/14/1998
Decision Date 01/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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