Controller, Closed-loop, Blood-pressure

Device Code: 2859

Product Code(s): LSX

Device Classification Information

Device Type ID2859
Device NameController, Closed-loop, Blood-pressure
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLSX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2859
DeviceController, Closed-loop, Blood-pressure
Product CodeLSX
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:20:09

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