| Device Type ID | 2553 |
| Device Name | Manometer, Spinal-fluid |
| Regulation Description | Spinal Fluid Manometer. |
| 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 | 880.2500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FMJ |
| 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 | 2553 |
| Device | Manometer, Spinal-fluid |
| Product Code | FMJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Fluid Manometer. |
| CFR Regulation Number | 880.2500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PAJUNK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAJUNK GMBH MEDIZINTECHNOLOGIE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 246 |
Needle | 213 |
Needle, Separation | 36 |
Fail-Safe Design Failure | 6 |
Difficult Or Delayed Activation | 3 |
Bent | 2 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Positioning Failure | 1 |
| Total Device Problems | 510 |