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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 K190208
Device Name Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Applicant
Diversatek Healthcare
9150 Commerce Center Circle
Suite 500
Highlands Ranch,  CO  80129
Applicant Contact Laura L. Boll
Correspondent
Diversatek Healthcare
9150 Commerce Center Circle
Suite 500
Highlands Ranch,  CO  80129
Correspondent Contact Laura L. Boll
Regulation Number876.1725
Classification Product Code
FFX  
Date Received02/04/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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