The following data is part of a premarket notification filed by Outset Medical, Inc. with the FDA for Tablo Cartridge.
| Device ID | K210782 |
| 510k Number | K210782 |
| Device Name: | Tablo Cartridge |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | Outset Medical, Inc. 3052 Orchard Drive San Jose, CA 95134 |
| Contact | Jennifer Mascioli-tudor |
| Correspondent | Claire Bao Outset Medical, Inc. 3052 Orchard Drive San Jose, CA 95134 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-16 |
| Decision Date | 2021-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001011273 | K210782 | 000 |
| 00850001011259 | K210782 | 000 |