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FDA 510(k), K190793, Tablo Hemodialysis System, Tablo Cartridge
FDA 510(k), K190793, Tablo Hemodialysis System, Tablo Cartridge
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510(K) Number: K190793
Device Name: Tablo Hemodialysis System, Tablo Cartridge
Manufacturer: Jennifer Mascioli-Tudor
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 03/28/2019
Decision Date: 12/12/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Tablo Hemodialysis System, Tablo Cartridge
Manufacturer: Jennifer Mascioli-Tudor
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 03/28/2019
Decision Date: 12/12/2019
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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