Lifecare Model 4 Pump
by Abbott Laboratories 510(k)
Active
510(k) K900467
Overview
The Lifecare Model 4 Pump is a Class II infusion pump intended for general hospital use. It is identified by the product code FRN and is classified under the FDA device class 2 category for infusion pumps.
The device was cleared through the FDA 510(k) pathway (K900467) on August 27, 1990, with a decision of substantially equivalent. It is supplied by Abbott Laboratories, located in Abbott Park, Illinois, and is listed under registration number 1123137.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900467 | Date27 Aug 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent