Device, Skin Potential Measurement

Device Code: 3727

Product Code(s): HCJ

Device Classification Information

Device Type ID3727
Device NameDevice, Skin Potential Measurement
Regulation DescriptionSkin Potential Measurement Device.
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) Exempt
CFR Regulation Number882.1560 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHCJ
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 ID3727
DeviceDevice, Skin Potential Measurement
Product CodeHCJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSkin Potential Measurement Device.
CFR Regulation Number882.1560 [🔎]
TPLC Last Update: 2019-04-02 20:35:30

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