Device Type ID | 3710 |
Device Name | Chair, Neurosurgical |
Regulation Description | Neurosurgical Chair. |
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 | 882.4125 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HBN |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3710 |
Device | Chair, Neurosurgical |
Product Code | HBN |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Neurosurgical Chair. |
CFR Regulation Number | 882.4125 [🔎] |
Device Problems | |
---|---|
Component Missing | 7 |
Product Quality Problem | 5 |
Device Operational Issue | 4 |
Material Fragmentation | 3 |
Device Issue | 2 |
Device Misassembled During Manufacturing / Shipping | 1 |
Incorrect Device Or Component Shipped | 1 |
Material Frayed | 1 |
Total Device Problems | 24 |