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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 K091070
Device Name MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
Applicant
Sierra Scientific Instruments, Inc.
5757 Century Blvd.
Suite 660
Los Angeles,  CA  90045
Applicant Contact REIC S FINKELMAN
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/14/2009
Decision Date 05/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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