LHF · Warmer, Microwave, Infusion Fluid
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | LHF |
|---|---|
| Device Name | Warmer, Microwave, Infusion Fluid |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K811726 | LEKSELL STEREOACTIC SYSTEM | Downs Surgical , Ltd. | Jul 10, 1981 | SESE |
| K811724 | 2M 9810 MICROWAVE OVEN | Travenol Laboratories, S.A. | Jul 10, 1981 | SESE |
Top Applicants
- Downs Surgical , Ltd. — 1 clearance
- Travenol Laboratories, S.A. — 1 clearance
