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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometer, Electrical Recording
510(k) Number K931574
Device Name ADVANCE MODEL UDS-ADV
Applicant
Laborie Medical Technologies, Ltd.
6415 Northwest Dr., Unit 11
Mississauga,  CA L4V 1X1
Applicant Contact FRED BUFFA
Correspondent
Laborie Medical Technologies, Ltd.
6415 Northwest Dr., Unit 11
Mississauga,  CA L4V 1X1
Correspondent Contact FRED BUFFA
Regulation Number876.1620
Classification Product Code
EXQ  
Date Received03/30/1993
Decision Date 08/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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