Omron Ultrasonic Nebulizer NE-U06
FDA 510(k)Class II (US FDA 510(k))
by Nidek, Inc.
Identifiers
- 510(k) Number
- K875134 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Omron Ultrasonic Nebulizer Ne-U06 is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. It is an ultrasonic nebulizer, which is a type of device that includes heated, ultrasonic, gas, venturi, and refillable nebulizers. This device is used to deliver medication to patients in aerosol form. The Omron Ultrasonic Nebulizer Ne-U06 is a specific model of nebulizer. It is used for breathing.
The Omron Ultrasonic Nebulizer Ne-U06 is supplied by Nidek, Inc. and has been found to be Substantially Equivalent by the FDA. The device has a product code of CAF and has been assigned the k number K875134. It is an FDA 510K authorized device. The device is used in anesthesiology and is available with the model number Ne-U06.
Frequently asked questions
What is the Omron Ultrasonic Nebulizer Ne-U06 used for?
The Omron Ultrasonic Nebulizer Ne-U06 is used to deliver medication to patients in aerosol form for breathing, particularly in anesthesiology.
Is the Omron Ultrasonic Nebulizer Ne-U06 a single-use device?
The description does not specify if the Omron Ultrasonic Nebulizer Ne-U06 is single-use or reusable, but it is an ultrasonic nebulizer designed for repeated use.
What is the regulatory status of the Omron Ultrasonic Nebulizer Ne-U06?
The Omron Ultrasonic Nebulizer Ne-U06 has been found to be Substantially Equivalent by the FDA and is authorized under FDA 510K with the k number K875134.
How is the Omron Ultrasonic Nebulizer Ne-U06 supplied?
The Omron Ultrasonic Nebulizer Ne-U06 is supplied by Nidek, Inc.
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: OMRON ULTRASONIC NEBULIZER NE-U06 - Innolitics, PDF K875134 - Omron Ultrasonic Nebulizer Ne-u06, OMRON ULTRASONIC NEBULIZER NE-U06 510(k) K875134 - FDA.report, OMRON Respiratory Nebulizers & Devices for At-Home Use
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K875134 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA 510(k) K875134 24 fields · synced Sep 22, 2026