Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P, AN4322P & AN3423P
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050919 FDA 510(k)
- FDA Product Code
- DSI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lifegard II Family Multi-Function Patient Monitor is a detector and alarm device designed for arrhythmia detection and monitoring. It is classified as a Class II medical device under FDA regulation 870.1025 and is intended for cardiovascular monitoring applications.
The device received FDA 510(k) clearance (K050919) on June 14, 2005, as substantially equivalent to a predicate device. It is manufactured by Analogic Corp. and supplied as a reusable system for use in clinical settings, with no indication of sterility, single-use designation, MRI safety, storage conditions, or size specifications provided in the data.
Frequently asked questions
What is the Lifegard II Family Multi-Function Patient Monitor used for?
It is designed as a detector and alarm device for arrhythmia detection and monitoring, intended for cardiovascular monitoring applications in clinical settings.
Is the Lifegard II Family Multi-Function Patient Monitor sterile or single-use?
The device is supplied as a reusable system with no indication of sterility or single-use designation in the provided data, meaning it is intended for repeated use after appropriate cleaning and disinfection.
What models are included in the Lifegard II Family Multi-Function Patient Monitor?
The family includes models AN4320, AN4320P, AN4321P, AN4322P, and AN3423P, all manufactured by Analogic Corp. and covered under the same FDA 510(k) clearance K050919.
How was the Lifegard II Family Multi-Function Patient Monitor regulated for market release?
It received FDA 510(k) clearance (K050919) on June 14, 2005, as substantially equivalent to a predicate device, and is classified as a Class II medical device under regulation 870.1025.
What regulatory classification applies to the Lifegard II Family Multi-Function Patient Monitor?
The device is classified as a Class II medical device under FDA regulation 870.1025, which covers detector and alarm devices for arrhythmia monitoring, based on its intended use and technological characteristics.
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 | K050919 | Class II | Active |
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Manufacturer
- Manufacturer
- Analogic Corp.
Sources (1)
- FDA 510(k) K050919 24 fields · synced Oct 6, 2026