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FDA 510(k)

Tablo Hemodialysis System, Tablo Cartridge

K-Number: K190793 · 2019-12-12

ApplicantOutset Medical, Inc.
Decision Date2019-12-12
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tablo Hemodialysis System, Tablo Cartridge is a medical device manufactured by Outset Medical, Inc.. It received FDA 510(k) clearance on 2019-12-12 under approval number K190793. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tablo Hemodialysis System, Tablo Cartridge?

Tablo Hemodialysis System, Tablo Cartridge is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Outset Medical, Inc.. The 510(k) number is K190793.

When was Tablo Hemodialysis System, Tablo Cartridge approved by the FDA?

Tablo Hemodialysis System, Tablo Cartridge received FDA 510(k) clearance on 2019-12-12, under approval number K190793.

What company makes Tablo Hemodialysis System, Tablo Cartridge?

Tablo Hemodialysis System, Tablo Cartridge is manufactured by Outset Medical, Inc..

What is the FDA product code for Tablo Hemodialysis System, Tablo Cartridge?

The FDA product code for Tablo Hemodialysis System, Tablo Cartridge is KDI.

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Other Devices by Outset Medical, Inc.

K160881Tablo Console K200741Tablo Hemodialysis System K210782Tablo Cartridge K211370Tablo Hemodialysis System K233335Tablo® Hemodialysis System K223248Tablo® Hemodialysis System

View all 9 devices →

Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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