Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1 Therapy Configuration
by Abbott Laboratories 510(k)
Active
510(k) K000821
Overview
The Abbott GemStar I.V. Infusion Pump is a medical device designed to deliver fluids and medications to patients. It is available in 7 therapy, 6 therapy, and 1 therapy configurations to support various clinical infusion requirements.
This device is intended for use by healthcare professionals, caregivers, and patients. It is regulated under FDA 510(k) authorization and is classified as an infusion pump.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000821 | Date24 Mar 2000 | 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- Withdrawn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
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the Abbott GemStar I.V. Infusion Pump?
The Abbott GemStar I.V. Infusion Pump is a medical device engineered to deliver medications and fluids to patients. It is designed for use by healthcare professionals, caregivers, and patients to meet various clinical infusion requirements.
What configuration options are available for this infusion pump?
The device is available in three distinct configurations: 7 therapy, 6 therapy, and 1 therapy. These options allow the pump to be tailored to specific clinical infusion needs.
What is the regulatory status of the Abbott GemStar I.V. Infusion Pump?
The Abbott GemStar I.V. Infusion Pump is regulated under FDA 510(k) authorization, which indicates it has been reviewed and cleared for market distribution as an infusion pump.