FDA device listing
Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
FDA device listing 1202292973 · Outset Medical, Inc.
Key facts
| Proprietary names | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer |
|---|---|
| Owner/operator | Outset Medical, Inc. |
| Owner/operator number | 10047467 |
| Premarket submissions | K232776 |
| Product codes | FIP, KDI |
| Device names | FIP - Subsystem, Water Purification, KDI - Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5665, 876.5860 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Baja Fur S.A. de C.V., Outset Medical, Inc. |
| Establishment registrations | 3010355846, 3017552925, 3038138522 |
| FEI numbers | 3010355846, 3017552925, 3038138522 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database