Discriminator, Two-point

Device Code: 3640

Product Code(s): GWI

Device Classification Information

Device Type ID3640
Device NameDiscriminator, Two-point
Regulation DescriptionTwo-point Discriminator.
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 Number882.1200 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGWI
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3640
DeviceDiscriminator, Two-point
Product CodeGWI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTwo-point Discriminator.
CFR Regulation Number882.1200 [🔎]
TPLC Last Update: 2019-04-02 20:33:39

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