| Device Type ID | 3709 |
| Device Name | Headrest, Neurosurgical |
| Regulation Description | Neurosurgical Headrests. |
| 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 | 882.4440 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HBM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3709 |
| Device | Headrest, Neurosurgical |
| Product Code | HBM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Neurosurgical Headrests. |
| CFR Regulation Number | 882.4440 [🔎] |
| Device Problems | |
|---|---|
Patient Device Interaction Problem | 1 |
Failure To Adhere Or Bond | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Electrode | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 6 |