The following data is part of a premarket notification filed by Dymedix Diagnostics, Inc. with the FDA for Rubicon Sa System.
| Device ID | K200654 |
| 510k Number | K200654 |
| Device Name: | Rubicon SA System |
| Classification | Ventilatory Effort Recorder |
| Applicant | Dymedix Diagnostics, Inc. 5985 Rice Creek Parkway Shoreview, MN 55126 |
| Contact | Jim Moore |
| Correspondent | Paul Dryden Dymedix Diagnostics, Inc. C/o ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-12 |
| Decision Date | 2020-07-22 |