The following data is part of a premarket notification filed by Outset Medical, Inc. with the FDA for Tablo Hemodialysis System, Tablo Cartridge.
| Device ID | K190793 |
| 510k Number | K190793 |
| Device Name: | Tablo Hemodialysis System, Tablo Cartridge |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Outset Medical, Inc. 1830 Bering Drive San Jose, CA 95112 |
| Contact | Jennifer Mascioli-tudor |
| Correspondent | Jennifer Mascioli-tudor Outset Medical, Inc. 1830 Bering Drive San Jose, CA 95112 |
| Product Code | KDI |
| Subsequent Product Code | FIP |
| Subsequent Product Code | FJK |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-28 |
| Decision Date | 2019-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001011181 | K190793 | 000 |
| 10850001011164 | K190793 | 000 |
| 10850001011133 | K190793 | 000 |
| 00850001011105 | K190793 | 000 |