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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Electrogastrography (Egg)
510(k) Number K014269
Device Name POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
16-18 TONSBAKKEN
SKOVLUNDE,  DK DK-2740
Applicant Contact TOVE KJAER
Correspondent
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
16-18 TONSBAKKEN
SKOVLUNDE,  DK DK-2740
Correspondent Contact TOVE KJAER
Regulation Number876.1735
Classification Product Code
MYE  
Date Received12/27/2001
Decision Date 11/21/2002
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
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