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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 K954798
Device Name 7100 SWALLOWING WORKSTATION
Applicant
Kay Elemetrics Corp.
2 Bridgewater Ln.
Lincoln Park,  NJ  07035 -1488
Applicant Contact WILLIAM D HARBESON
Correspondent
Kay Elemetrics Corp.
2 Bridgewater Ln.
Lincoln Park,  NJ  07035 -1488
Correspondent Contact WILLIAM D HARBESON
Regulation Number876.1725
Classification Product Code
KLA  
Date Received10/18/1995
Decision Date 06/04/1996
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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