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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 K905154
Device Name GASTROSCAN
Applicant
Medics Instrument Corp.
Friedhofplatz 16, Pob 706
Ch-4502
Solothurn, Switzerland,  SE
Applicant Contact JOHN MATHERLY
Correspondent
Medics Instrument Corp.
Friedhofplatz 16, Pob 706
Ch-4502
Solothurn, Switzerland,  SE
Correspondent Contact JOHN MATHERLY
Regulation Number876.1725
Classification Product Code
FFX  
Date Received11/15/1990
Decision Date 06/19/1991
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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