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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, cystometric, hydraulic
510(k) Number K992715
Device Name NEURO URODYNAMIC SUITE, MODEL 9032E0101
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 Number876.1620
Classification Product Code
FEN  
Subsequent Product Codes
GWF   JXE  
Date Received08/12/1999
Decision Date 02/28/2000
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
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