Definition: For Use As An Assessment Aid In The Management Of Concussion.
Device Type ID | 3791 |
Device Name | Computerized Cognitive Assessment Aid For Concussion |
Physical State | The 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 Method | Uses A Software-based Cognitive Test Battery As An Assessment Aid In The Management Of Concussion. |
Target Area | Brain |
Regulation Description | Computerized Cognitive Assessment Aid For Concussion. |
Regulation Medical Specialty | Neurology |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
Submission Type | 510(k) |
CFR Regulation Number | 882.1471 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | POM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3791 |
Device | Computerized Cognitive Assessment Aid For Concussion |
Product Code | POM |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Computerized Cognitive Assessment Aid For Concussion. |
CFR Regulation Number | 882.1471 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
IMPACT APPLICATIONS, INC | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 |