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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 K010130
Device Name POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
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 Number876.1725
Classification Product Code
FFX  
Date Received01/16/2001
Decision Date 02/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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