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 | ||
|---|---|---|
| Manufacturer | Decision | |
IMPACT APPLICATIONS, INC | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |