Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
| Device Type ID | 3801 |
| Device Name | Neurological Test Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217. |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217. |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217. |
| Regulation Description | Pinwheel. |
| 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 | Enforcement Discretion |
| CFR Regulation Number | 882.1750 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PVP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3801 |
| Device | Neurological Test Kit |
| Product Code | PVP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pinwheel. |
| CFR Regulation Number | 882.1750 [🔎] |