Avi Model 840 Dual Channel Infusion Pump
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K900204 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Avi Model 840 Dual Channel Infusion Pump is a pump, infusion device intended for general hospital use. It is a dual-channel infusion pump designed to deliver fluids or medications with precise control.
This device is supplied as a reusable infusion pump and is classified as a Class II medical device under FDA regulation number 880.5725. It received FDA 510(k) clearance (K900204) on April 3, 1990, and is substantially equivalent to a legally marketed device. The device is manufactured by 3M Company and is intended for use in general hospital settings.
Frequently asked questions
What is the Avi Model 840 Dual Channel Infusion Pump used for?
The Avi Model 840 Dual Channel Infusion Pump is intended for general hospital use to deliver fluids or medications with precise control, as it is a dual-channel infusion pump designed for accurate infusion therapy.
Is the Avi Model 840 Dual Channel Infusion Pump reusable or single-use?
The Avi Model 840 Dual Channel Infusion Pump is supplied as a reusable infusion pump, meaning it is designed for multiple uses after proper cleaning and maintenance, not for single-use disposal.
What regulatory pathway was used for the Avi Model 840 Dual Channel Infusion Pump?
The Avi Model 840 Dual Channel Infusion Pump received FDA 510(k) clearance (K900204) on April 3, 1990, and is classified as a Class II medical device under FDA regulation number 880.5725, indicating it was found substantially equivalent to a legally marketed device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900204 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K900204 24 fields · synced Sep 21, 2026