The following data is part of a premarket notification filed by Dosis, Inc. with the FDA for Dosis Sam.
| Device ID | K180410 |
| 510k Number | K180410 |
| Device Name: | Dosis SAM |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | Dosis, Inc. 4388 El Camino Real, Unit 330 Los Altos, CA 94022 |
| Contact | Divya Chhabra |
| Correspondent | E.j. Smith Smith Assoicates 1468 Harwell Ave Crofton, MD 21114 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-14 |
| Decision Date | 2019-01-16 |
| Summary: | summary |