Device Type ID | 3727 |
Device Name | Device, Skin Potential Measurement |
Regulation Description | Skin Potential Measurement Device. |
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 | 882.1560 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HCJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3727 |
Device | Device, Skin Potential Measurement |
Product Code | HCJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Skin Potential Measurement Device. |
CFR Regulation Number | 882.1560 [🔎] |