Generator, Electroencephalograph Test Signal

Device Code: 3648

Product Code(s): GWR

Device Classification Information

Device Type ID3648
Device NameGenerator, Electroencephalograph Test Signal
Regulation DescriptionElectroencephalograph Test Signal Generator.
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 Number882.1430 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGWR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3648
DeviceGenerator, Electroencephalograph Test Signal
Product CodeGWR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionElectroencephalograph Test Signal Generator.
CFR Regulation Number882.1430 [🔎]
TPLC Last Update: 2019-04-02 20:33:48

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.