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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 the device name listed in this FDA 510(k) record. The listed applicant is Outset Medical, Inc.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) 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. The listed applicant is Outset Medical, Inc.. The 510(k) number is K211370.

When did Tablo Hemodialysis System receive FDA 510(k) clearance?

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

Who is the listed applicant for Tablo Hemodialysis System?

The FDA 510(k) record lists Outset Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tablo Hemodialysis System?

The FDA product code for Tablo Hemodialysis System is KDI.

Other records listing Outset Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerK233335Tablo® Hemodialysis SystemK223248Tablo® Hemodialysis SystemK210782Tablo CartridgeK200741Tablo Hemodialysis System

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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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