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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intracompartmental
510(k) Number K242997
Device Name MY01 Continuous Compartmental Pressure Monitor
Applicant
MY01 Inc.
400 De Maisonneuve Boulevard West, Suite 700
Montreal,  CA H3A 1L4
Applicant Contact Olivier Bataille
Correspondent
MY01 Inc.
400 De Maisonneuve Boulevard West, Suite 700
Montreal,  CA H3A 1L4
Correspondent Contact Olivier Bataille
Classification Product Code
LXC  
Date Received09/26/2024
Decision Date 03/13/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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