MY01 Continuous Compartmental Pressure Monitor

Monitor, Pressure, Intracompartmental

MY01 Inc.

The following data is part of a premarket notification filed by My01 Inc. with the FDA for My01 Continuous Compartmental Pressure Monitor.

Pre-market Notification Details

Device IDK210525
510k NumberK210525
Device Name:MY01 Continuous Compartmental Pressure Monitor
ClassificationMonitor, Pressure, Intracompartmental
Applicant MY01 Inc. 400 De Maisonneuve Boulevard West, Suite 700 Montreal,  CA H3a 1la
ContactCharles Allan
CorrespondentAnthony Sirgi
MY01 Inc. 400 De Maisonneuve Boulevard West, Suite 700 Montreal,  CA H3a 1la
Product CodeLXC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-23
Decision Date2021-04-22

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