Rateminder V Infusion Pump, Modification
by Critikon Company, LLC 510(k)
Active
510(k) K911769
Overview
The Rateminder V Infusion Pump, Modification is an infusion pump used to deliver fluids into a patient's body in a controlled manner. It is classified as an infusion pump under regulation number 880.5725.
This device is intended for use in a general hospital setting. It received FDA 510(k) clearance under the number K911769.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911769 | Date3 Jun 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Rateminder(Tm) V Infusion Pump, Modification
- 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