Device Type ID | 3640 |
Device Name | Discriminator, Two-point |
Regulation Description | Two-point Discriminator. |
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 | 882.1200 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | GWI |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3640 |
Device | Discriminator, Two-point |
Product Code | GWI |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Two-point Discriminator. |
CFR Regulation Number | 882.1200 [🔎] |