Monitor, Pressure, Intracompartmental

Device Code: 4714

Product Code(s): LXC

Device Classification Information

Device Type ID4714
Device NameMonitor, Pressure, Intracompartmental
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLXC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4714
DeviceMonitor, Pressure, Intracompartmental
Product CodeLXC
Premarket Reviews
ManufacturerDecision
TWIN STAR MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Device Operates Differently Than Expected
2
Device Displays Incorrect Message
1
Unable To Obtain Readings
1
Probe
1
Total Device Problems 5
TPLC Last Update: 2019-04-02 20:54:20

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