The following data is part of a premarket notification filed by My01 Inc. with the FDA for My01 Continuous Compartmental Pressure Monitor.
| Device ID | K210525 |
| 510k Number | K210525 |
| Device Name: | MY01 Continuous Compartmental Pressure Monitor |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | MY01 Inc. 400 De Maisonneuve Boulevard West, Suite 700 Montreal, CA H3a 1la |
| Contact | Charles Allan |
| Correspondent | Anthony Sirgi MY01 Inc. 400 De Maisonneuve Boulevard West, Suite 700 Montreal, CA H3a 1la |
| 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 | 2021-02-23 |
| Decision Date | 2021-04-22 |