| Device Type ID | 2546 |
| Device Name | Monitor, Electric For Gravity Flow Infusion Systems |
| Regulation Description | Electronic Monitor For Gravity Flow Infusion Systems. |
| 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 | 880.2420 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FLN |
| 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 | 2546 |
| Device | Monitor, Electric For Gravity Flow Infusion Systems |
| Product Code | FLN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electronic Monitor For Gravity Flow Infusion Systems. |
| CFR Regulation Number | 880.2420 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COLEMAN LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHIFT LABS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 1 |
| Total Device Problems | 1 |