Device Type ID | 3686 |
Device Name | Electrode, Nasopharyngeal |
Regulation Description | Nasopharyngeal Electrode. |
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 | 882.1340 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | GZK |
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 | 3686 |
Device | Electrode, Nasopharyngeal |
Product Code | GZK |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Nasopharyngeal Electrode. |
CFR Regulation Number | 882.1340 [🔎] |