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FDA 510(k)

Tablo Hemodialysis System

K-Number: K211370 · 2022-07-29

ApplicantOutset Medical, Inc.
Decision Date2022-07-29
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tablo Hemodialysis System is a medical device manufactured by Outset Medical, Inc.. It received FDA 510(k) clearance on 2022-07-29 under approval number K211370. 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 Hemodialysis System is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Outset Medical, Inc.. The 510(k) number is K211370.

When was Tablo Hemodialysis System approved by the FDA?

Tablo Hemodialysis System received FDA 510(k) clearance on 2022-07-29, under approval number K211370.

What company makes Tablo Hemodialysis System?

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

What is the FDA product code for Tablo Hemodialysis System?

The FDA product code for Tablo Hemodialysis System is KDI.

Related Clinical Trials

NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING NCT07522944 AI-Guided Relaxation for Hemodialysis Anxiety RECRUITING NCT07538310 Laser Acupuncture for Fatigue in Hemodialysis Patients NOT_YET_RECRUITING NCT07216885 Solv Multi-Pass Hemodialysis System In-Center Clinical Study RECRUITING

Other Devices by Outset Medical, Inc.

K160881Tablo Console K190793Tablo Hemodialysis System, Tablo Cartridge K200741Tablo Hemodialysis System K210782Tablo Cartridge 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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