Tester, Electrode/lead, Electroencephalograph

Device Code: 3674

Product Code(s): GYA

Device Classification Information

Device Type ID3674
Device NameTester, Electrode/lead, Electroencephalograph
Regulation DescriptionElectroencephalograph Electrode/lead Tester.
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 Number882.1410 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGYA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3674
DeviceTester, Electrode/lead, Electroencephalograph
Product CodeGYA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionElectroencephalograph Electrode/lead Tester.
CFR Regulation Number882.1410 [🔎]
TPLC Last Update: 2019-04-02 20:34:12

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