Identifiers
- 510(k) Number
- K162785 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 Velox Nebulizer System is a mobile vibrating membrane nebulizer designed for efficient aerosol therapy in the treatment of acute and chronic airway diseases such as COPD, asthma, and bronchitis. It provides high aerosol output with a large proportion of lung-deposable droplets and operates extremely quietly for discreet treatment.
This device is supplied by PARI Respiratory Equipment, Inc. and has received FDA 510(k) clearance with the product code CAF. The Velox Nebulizer System is intended for use in respiratory therapy applications, though specific details regarding sterility, single-use or reusable status, MRI safety, and storage conditions are not provided in the available data.
Frequently asked questions
What is the Velox Nebulizer System used for?
The Velox Nebulizer System is designed for efficient aerosol therapy in treating acute and chronic airway diseases such as COPD, asthma, and bronchitis. It provides high aerosol output with a large proportion of lung-deposable droplets.
How is the Velox Nebulizer System supplied?
The Velox Nebulizer System is supplied by PARI Respiratory Equipment, Inc. The available data does not specify details regarding sterility, single-use or reusable status, MRI safety, or storage conditions.
What regulatory approvals does the Velox Nebulizer System have?
The Velox Nebulizer System has received FDA 510(k) clearance with the product code CAF. It was determined to be substantially equivalent through a traditional clearance process.
What are the key features of the Velox Nebulizer System?
The Velox Nebulizer System is a mobile vibrating membrane nebulizer that operates extremely quietly for discreet treatment. It provides high aerosol output with a large proportion of lung-deposable droplets for effective respiratory therapy.
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: Velox® - Pari, Products - PARI, Nebulizers - PARI Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162785 | Class II | Active |
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Manufacturer
- Manufacturer
- Pari Respiratory Equipment, Inc.
Sources (1)
- FDA 510(k) K162785 24 fields · synced Sep 28, 2026