Definition: This Product Code Is The Class II Exempt Counterpart Of PKQ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k))
| Device Type ID | 3797 |
| Device Name | Computerized Cognitive Assessment Aid, Exempt |
| Physical State | Exemption Applies Only To Computerized Cognitive Assessment Aids That Are Not Used For Diagnostic Assessment For Specific Diseases Or Conditions And Rely On Inputs From Visual Cues, Auditory Cues, And/or Functional Use Of The Hand. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of PKQ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Target Area | This Product Code Is The Class II Exempt Counterpart Of PKQ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Regulation Description | Computerized Cognitive Assessment Aid. |
| 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) Exempt |
| CFR Regulation Number | 882.1470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3797 |
| Device | Computerized Cognitive Assessment Aid, Exempt |
| Product Code | PTY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Computerized Cognitive Assessment Aid. |
| CFR Regulation Number | 882.1470 [🔎] |