Device Classification Name |
Monitor, Pressure, Intracompartmental
|
510(k) Number |
K193321 |
Device Name |
MY01 Continuous Compartmental Pressure Monitor |
Applicant |
MY01, Inc. |
85 Rue Saint-Paul Ouest, Suite 200 |
Montreal,
CA
H2Y 3V4
|
|
Applicant Contact |
Charles Allan |
Correspondent |
MY01, Inc. |
85 Rue Saint-Paul Ouest, Suite 200 |
Montreal,
CA
H2Y 3V4
|
|
Correspondent Contact |
Charles Allan |
Classification Product Code |
|
Date Received | 12/02/2019 |
Decision Date | 07/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|