Echoencephalograph

Device Code: 3670

Product Code(s): GXW

Device Classification Information

Device Type ID3670
Device NameEchoencephalograph
Regulation DescriptionEchoencephalograph.
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 Number882.1240 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGXW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID3670
DeviceEchoencephalograph
Product CodeGXW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEchoencephalograph.
CFR Regulation Number882.1240 [🔎]
TPLC Last Update: 2019-04-02 20:34:08

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