The following data is part of a premarket notification filed by Outset Medical, Inc. with the FDA for Tablo Console.
| Device ID | K160881 |
| 510k Number | K160881 |
| Device Name: | Tablo Console |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | OUTSET MEDICAL, INC. 1830 BERING DRIVE San Jose, CA 95112 |
| Contact | Leslie Trigg |
| Correspondent | Julie Newsome OUTSET MEDICAL, INC. 1830 BERING DRIVE San Jose, CA 95112 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-30 |
| Decision Date | 2016-11-15 |
| Summary: | summary |