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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 K981733
Device Name DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
Applicant
Medtronic Functional Diagnostics A/S
16-18 Tonsbakken
Skovlunde,  DK DK-2740
Applicant Contact ANN-CHRISTINE JONSSON
Correspondent
Medtronic Functional Diagnostics A/S
16-18 Tonsbakken
Skovlunde,  DK DK-2740
Correspondent Contact ANN-CHRISTINE JONSSON
Regulation Number876.1725
Classification Product Code
FFX  
Date Received05/18/1998
Decision Date 02/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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