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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K212658
Device Name CloudCath Peritoneal Dialysis Drain Set Monitoring System
Applicant
Cloudcath
665 3rd St., Suite 250
San Francisco,  CA  94107
Applicant Contact Brian Fisher
Correspondent
Cloudcath
665 3rd St., Suite 250
San Francisco,  CA  94107
Correspondent Contact Brian Fisher
Regulation Number876.5630
Classification Product Code
FKX  
Date Received08/23/2021
Decision Date 02/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT04515498
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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