Fork, Tuning

Device Code: 3651

Product Code(s): GWX

Device Classification Information

Device Type ID3651
Device NameFork, Tuning
Regulation DescriptionTuning Fork.
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 Number882.1525 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGWX
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3651
DeviceFork, Tuning
Product CodeGWX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTuning Fork.
CFR Regulation Number882.1525 [🔎]
TPLC Last Update: 2019-04-02 20:33:50

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