Stimulator, Nerve, Ac-powered

Device Code: 37

Product Code(s): BXM

Device Classification Information

Device Type ID37
Device NameStimulator, Nerve, Ac-powered
Regulation DescriptionElectrical Peripheral Nerve Stimulator.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.2775 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBXM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID37
DeviceStimulator, Nerve, Ac-powered
Product CodeBXM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrical Peripheral Nerve Stimulator.
CFR Regulation Number868.2775 [🔎]
TPLC Last Update: 2019-04-02 19:27:14

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