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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K941801
Device Name ANALGRAPH
Applicant
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120
Applicant Contact LINDA L DIEDERICH
Correspondent
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120
Correspondent Contact LINDA L DIEDERICH
Regulation Number876.1725
Classification Product Code
KLA  
Subsequent Product Code
FFX  
Date Received04/12/1994
Decision Date 09/08/1995
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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