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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 K884527
Device Name ZINETICS(R) EMC
Applicant
Zinetics Medical, Inc.
Forty-Eight Tempest Park
2212 S. W. Temple
Salt Lake City,  UT  84115
Applicant Contact RUSS GARRISON
Correspondent
Zinetics Medical, Inc.
Forty-Eight Tempest Park
2212 S. W. Temple
Salt Lake City,  UT  84115
Correspondent Contact RUSS GARRISON
Regulation Number876.1725
Classification Product Code
KLA  
Date Received10/27/1988
Decision Date 02/28/1989
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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