MHD · Pump, Infusion, Gallstone Dissolution
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | MHD |
|---|---|
| Device Name | Pump, Infusion, Gallstone Dissolution |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993907 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 | Agilent Technologies, Inc. | Dec 6, 1999 | SESE |
Top Applicants
- Agilent Technologies, Inc. — 1 clearance
