Electrode, Nasopharyngeal

Device Code: 3686

Product Code(s): GZK

Device Classification Information

Device Type ID3686
Device NameElectrode, Nasopharyngeal
Regulation DescriptionNasopharyngeal Electrode.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
CFR Regulation Number882.1340 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGZK
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 ID3686
DeviceElectrode, Nasopharyngeal
Product CodeGZK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNasopharyngeal Electrode.
CFR Regulation Number882.1340 [🔎]
TPLC Last Update: 2019-04-02 20:34:30

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