Invacare Check O2 Plus Concentrator Analyzer (check O2 Plus)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984295 FDA 510(k)
- FDA Product Code
- CCL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1720 FDA 510(k)
- Regulation Number
- 868.1720 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Invacare Check O₂ Plus Concentrator Analyzer is a medical device classified as an Analyzer, Gas, Oxygen, Gaseous-Phase, designed to measure and verify the performance of oxygen concentrators. It evaluates oxygen purity concentration, flow rate, and outlet pressure to ensure safe and accurate oxygen delivery for patients.
This device is intended for use in clinical and home settings by trained technicians. It is a reusable instrument, supplied as a standalone unit, and does not require sterilization. The analyzer operates in non-MRI environments and is authorized under FDA 510K clearance (K984295). No specific sterility or single-use designation is indicated in the regulatory data.
Frequently asked questions
What is the primary purpose of the Invacare Check O₂ Plus Concentrator Analyzer in clinical and home settings?
The Invacare Check O₂ Plus Concentrator Analyzer is designed to measure and verify the performance of oxygen concentrators by evaluating key parameters like oxygen purity concentration, flow rate, and outlet pressure. This ensures that oxygen delivery systems are functioning safely and accurately for patient use, which is critical in both clinical and homecare environments.
Is the Invacare Check O₂ Plus Concentrator Analyzer intended for single-use or reusable applications?
The device is explicitly described as a reusable instrument, meaning it is not meant for single-use. It is supplied as a standalone unit and does not require sterilization, making it suitable for repeated use in oxygen concentrator maintenance and verification.
How is the Invacare Check O₂ Plus Concentrator Analyzer authorized for use in the United States?
The device holds FDA 510(k) clearance under the classification of an Analyzer, Gas, Oxygen, Gaseous-Phase. The clearance number is K984295, and it was granted as substantially equivalent to a predicate device, with the decision made by the FDA’s Anesthesiology Advisory Committee in 1999.
Can the Invacare Check O₂ Plus Concentrator Analyzer be used in an MRI environment?
The device is explicitly designed for use in non-MRI environments, so it should not be used in or near MRI facilities where magnetic fields are present.
What types of oxygen concentrators is the Invacare Check O₂ Plus Concentrator Analyzer compatible with?
While the device is not explicitly limited to specific models, its regulatory data includes multiple product codes (e.g., CCL) associated with oxygen concentrators. It is intended for general use in verifying the performance of oxygen concentrators in clinical and home settings, ensuring compliance with safety standards for oxygen delivery systems.
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. Sources consulted: Invacare Check O2 Plus Oxygen Analyzer - IRC450, Invacare CheckO2 Plus oxygen analyser - Invacare, Invacare – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984295 | Class II | Active |
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Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA 510(k) K984295 24 fields · synced Sep 20, 2026