Mobilaire V & III PRO2 Oxygen Sensors Features
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K924818 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mobilaire V & III Pro2 Oxygen Sensors Features are components for portable oxygen concentrators that measure oxygen levels in the device's output. These sensors are designed to work with the Mobilaire V and III Pro2 oxygen concentrator models to monitor oxygen concentration.
The sensors are supplied as part of the oxygen concentrator system and are not described as single-use or reusable in the provided data. The device has FDA 510(k) clearance with product code CAW and is classified as a Generator, Oxygen, Portable. No specific information regarding MRI safety, sterility, or storage conditions is provided in the data.
Frequently asked questions
Are these oxygen sensors designed for single-use or can they be reused with the Mobilaire V & III Pro2 oxygen concentrators?
The provided data does not specify whether the Mobilaire V & III Pro2 Oxygen Sensors are single-use or reusable. Since they are described as components supplied *as part of the oxygen concentrator system*, their intended lifespan would typically align with the concentrator’s maintenance schedule, but this requires confirmation from Invacare Corp. or the device’s user manual.
What is the primary purpose of these oxygen sensors in the Mobilaire V & III Pro2 system?
These sensors measure oxygen levels in the output of the Mobilaire V & III Pro2 portable oxygen concentrators. Their role is to monitor and ensure the delivered oxygen concentration remains accurate and within the intended therapeutic range for the patient.
How are these sensors regulated in the U.S., and what does the product code CAW indicate?
The Mobilaire V & III Pro2 Oxygen Sensors have FDA 510(k) clearance, meaning they are classified as *substantially equivalent* to a predicate device. The product code CAW categorizes them under *Generators, Oxygen, Portable*, confirming their use in delivering portable oxygen therapy. This classification aligns with their function as monitoring components for oxygen concentrators.
Are there any special storage requirements mentioned for these oxygen sensors?
The provided data does not include specific storage conditions (e.g., temperature, humidity, or handling instructions) for the Mobilaire V & III Pro2 Oxygen Sensors. For proper maintenance and longevity, it’s recommended to follow Invacare Corp.’s guidelines or consult the device’s technical documentation, as environmental factors could impact sensor performance.
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: Mobilaire V & Iii Pro2 Oxygen Sensors Features, Mobilaire V & Iii Pro2 Oxygen Sensors Features, Invacare Mobilaire V Oxygen Concentrator, MOBILAIRE III P3 OXYGEN CONCENTRATOR (K851434) - FDA 510 (k), PDF K904087 Mobilaire Iii and V Model Irc 301 and 501 Oxy.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K924818 | Class II | Active |
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Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA 510(k) K924818 24 fields · synced Sep 19, 2026