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 IDK200741
510k NumberK200741
Device Name:Tablo Hemodialysis System
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Outset Medical, Inc. 1830 Bering Drive San Jose,  CA  95112
ContactJennifer Mascioli-tudor
CorrespondentJennifer Mascioli-tudor
Outset Medical, Inc. 1830 Bering Drive San Jose,  CA  95112
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2020-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850001011204 K200741 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.