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510(k) K212658

CloudCath Peritoneal Dialysis Drain Set Monitoring System by Cloudcath — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2022
Date Received
August 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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