Identifiers
- 510(k) Number
- K200741 FDA 510(k)
- FDA Product Code
- KDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tablo Hemodialysis System is a high permeability dialyzer with or without a sealed dialysate system. It is designed to perform hemodialysis treatments for patients.
This device has received FDA 510K clearance. It is intended for use in clinical settings.
Frequently asked questions
What is the primary function of the Tablo Hemodialysis System?
The Tablo Hemodialysis System is a high permeability dialyzer designed to perform hemodialysis treatments for patients.
In what environment is this device intended to be used?
The device is intended for use in clinical settings, as specified in its regulatory documentation.
Does the Tablo Hemodialysis System have regulatory authorization?
Yes, the device has received FDA 510K clearance, which indicates it has been reviewed and cleared for use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tablo Hemodialysis System - Outset Medical, Outset Medical, Tablo by Outset Medical | SDV Medical, Next-Generation Tablo Hemodialysis System Receives FDA Clearance ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200741 | Class II | Active |
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Manufacturer
- Manufacturer
- Outset Medical, Inc.
Sources (1)
- FDA 510(k) K200741 24 fields · synced Sep 26, 2026