The following data is part of a premarket notification filed by My01, Inc. with the FDA for My01 Continuous Compartmental Pressure Monitor.
| Device ID | K193321 |
| 510k Number | K193321 |
| Device Name: | MY01 Continuous Compartmental Pressure Monitor |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | MY01, Inc. 85 Rue Saint-Paul Ouest, Suite 200 Montreal, CA H2y 3v4 |
| Contact | Charles Allan |
| Correspondent | Charles Allan MY01, Inc. 85 Rue Saint-Paul Ouest, Suite 200 Montreal, CA H2y 3v4 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-07-30 |