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FDA 510(k), K212658, CloudCath Peritoneal Dialysis Drain Set Monitoring System
FDA 510(k), K212658, CloudCath Peritoneal Dialysis Drain Set Monitoring System
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$149.00 USD
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510(K) Number: K212658
Device Name: CloudCath Peritoneal Dialysis Drain Set Monitoring System
Manufacturer: CloudCath
Device Classification Name: System, Peritoneal, Automatic Delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 08/23/2021
Decision Date: 02/09/2022
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CloudCath Peritoneal Dialysis Drain Set Monitoring System
Manufacturer: CloudCath
Device Classification Name: System, Peritoneal, Automatic Delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 08/23/2021
Decision Date: 02/09/2022
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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