Devilbiss Model 4650 Compressor Neubulizer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K931015 FDA 510(k)
- FDA Product Code
- BTI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.6250 FDA 510(k)
- Regulation Number
- 868.6250 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Devilbiss Model 4650 Compressor Nebulizer is an AC powered air compressor designed to provide a source of compressed air for home health care use. It functions in conjunction with a jet pneumatic nebulizer to convert liquid medication into an aerosol form for inhalation into the patient's respiratory tract.
This device is intended for the treatment of respiratory conditions. It is regulated under FDA 510(k) clearance number K931015.
Frequently asked questions
What is the primary function of the Devilbiss Model 4650?
This device is an AC powered air compressor intended for home health care use. It functions by providing a source of compressed air to a jet pneumatic nebulizer, which converts liquid medication into an aerosol form suitable for inhalation into the patient's respiratory tract.
What is this device intended to treat?
The Model 4650 is intended for the treatment of respiratory conditions by facilitating the delivery of aerosolized medication to the patient's respiratory system.
Is this device regulated by the FDA?
Yes, this device is regulated under FDA 510(k) clearance number K931015. This indicates that the device has been reviewed and cleared for market distribution through the traditional 510(k) process.
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: Medizinische Hilfsmittel - Drive Medical, Devilbiss Model 4650 Compressor Nebulizer, DEVILBISS 4650D INSTRUCTION MANUAL Pdf Download | ManualsLib, DeVilbiss 4650 D Compressor/Nebulizer User manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K931015 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Devilbiss Health Care, Inc.
Sources (1)
- FDA 510(k) K931015 24 fields · synced Sep 21, 2026