Tablo Hemodialysis System

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Outset Medical, Inc.

The following data is part of a premarket notification filed by Outset Medical, Inc. with the FDA for Tablo Hemodialysis System.

Pre-market Notification Details

Device IDK211370
510k NumberK211370
Device Name:Tablo Hemodialysis System
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Outset Medical, Inc. 3052 Orchard Drive San Jose,  CA  95134
ContactJennifer Mascioli-Tudor
CorrespondentJennifer Mascioli-Tudor
Outset Medical, Inc. 3052 Orchard Drive San Jose,  CA  95134
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2022-07-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.