Device Type ID | 2535 |
Device Name | Monitor, Spinal-fluid Pressure, Electrically Powered |
Regulation Description | Electrically Powered Spinal Fluid Pressure Monitor. |
Regulation Medical Specialty | General Hospital |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | 510(k) |
CFR Regulation Number | 880.2460 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CAR |
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 | 2535 |
Device | Monitor, Spinal-fluid Pressure, Electrically Powered |
Product Code | CAR |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Electrically Powered Spinal Fluid Pressure Monitor. |
CFR Regulation Number | 880.2460 [🔎] |