The following data is part of a premarket notification filed by Outset Medical, Inc. with the FDA for Tablo Hemodialysis System.
| Device ID | K211370 |
| 510k Number | K211370 |
| Device Name: | Tablo Hemodialysis System |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Outset Medical, Inc. 3052 Orchard Drive San Jose, CA 95134 |
| Contact | Jennifer Mascioli-Tudor |
| Correspondent | Jennifer Mascioli-Tudor Outset Medical, Inc. 3052 Orchard Drive San Jose, CA 95134 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2022-07-29 |