Recorder, Attention Task Performance

Device Code: 3837

Product Code(s): LQD

Device Classification Information

Device Type ID3837
Device NameRecorder, Attention Task Performance
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)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLQD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3837
DeviceRecorder, Attention Task Performance
Product CodeLQD
Premarket Reviews
ManufacturerDecision
ANTHROTRONIX, INC
 
SUBSTANTIALLY EQUIVALENT
1
QBTECH AB
 
SUBSTANTIALLY EQUIVALENT
2
THE TOVA COMPANY
 
SUBSTANTIALLY EQUIVALENT
2
TPLC Last Update: 2019-04-02 20:38:08

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