Computerized Cognitive Assessment Aid For Concussion

Device Code: 3791

Product Code(s): POM

Definition: For Use As An Assessment Aid In The Management Of Concussion.

Device Classification Information

Device Type ID3791
Device NameComputerized Cognitive Assessment Aid For Concussion
Physical StateThe Device Consists Of A Software Program That Administers A Neurocognitive Test Battery To A Subject In Order To Assess Their Cognitive Status. The Device May Use Off-the-shelf Computers Or A Novel Device.
Technical MethodUses A Software-based Cognitive Test Battery As An Assessment Aid In The Management Of Concussion.
Target AreaBrain
Regulation DescriptionComputerized Cognitive Assessment Aid For Concussion.
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 Number882.1471 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePOM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3791
DeviceComputerized Cognitive Assessment Aid For Concussion
Product CodePOM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionComputerized Cognitive Assessment Aid For Concussion.
CFR Regulation Number882.1471 [🔎]
Premarket Reviews
ManufacturerDecision
IMPACT APPLICATIONS, INC
 
GRANTED
1
 
SUBSTANTIALLY EQUIVALENT
2
TPLC Last Update: 2019-04-02 20:36:59

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