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FDA 510(k), K181991, NxStage Connected Health System
FDA 510(k), K181991, NxStage Connected Health System
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510(K) Number: K181991
Device Name: NxStage Connected Health System
Manufacturer: Christina Marabella
Device Classification Name: System, Dialysate Delivery, Single Patient
Regulation Number: FKP
Classification Product Code: KXA
Date Received: 07/26/2018
Decision Date: 09/26/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NxStage Connected Health System
Manufacturer: Christina Marabella
Device Classification Name: System, Dialysate Delivery, Single Patient
Regulation Number: FKP
Classification Product Code: KXA
Date Received: 07/26/2018
Decision Date: 09/26/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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