FDA.reportPublic FDA data

510(k) K220952

Device
MY01 Continuous Compartmental Pressure Monitor
Applicant
MY01, Inc.
510(k) number
K220952
Product code
LXC
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-24
Date received
2022-04-01
Classification name
Monitor, Pressure, Intracompartmental
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charles Allen
Address
400 De Maisonneuve Blvd. W. Suite 700 Montreal CA H3A 1L4 H3A 1L4

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LXC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K090961TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)Twin Star Medical, Inc.2009-06-12
K060963TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)Twin Star Medical2006-06-06
K041771TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEMTwin Star Medical, Inc.2004-09-14
K031555SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEMSynthes (Usa)2003-07-08
K881858ACE ICPM SIDE PORTED NEEDLEBuckman Co., Inc.1988-05-27
K873684ACE INTRA COMPARTMENTAL PRESSURE MONITORAce Medical Co.1988-01-20
K844214COMPARTMENT SYNDROME PRESSURE MONITOR SYSStryker Corp.1985-04-04