Valve, Switching (ploss)

Device Code: 135

Product Code(s): JFE

Device Classification Information

Device Type ID135
Device NameValve, Switching (ploss)
Regulation DescriptionSwitching Valve (ploss).
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(K) Exempt
CFR Regulation Number868.1965 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJFE
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID135
DeviceValve, Switching (ploss)
Product CodeJFE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSwitching Valve (ploss).
CFR Regulation Number868.1965 [🔎]
TPLC Last Update: 2019-04-02 19:29:32

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