Vega CPAP System/Heated Humidifier, Model CP-03
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102625 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vega CPAP System/Heated Humidifier, Model CP-03, is a Continuous Positive Airway Pressure (CPAP) device designed to maintain open airways during sleep. It delivers a continuous stream of pressurized air to patients with obstructive sleep apnea, reducing apnea and hypopnea events by preventing airway collapse. The system integrates a heated humidifier to condition the air, improving patient comfort and compliance by reducing dryness and irritation.
This device is intended for use in clinical and home settings, supplied as a reusable system with disposable components where applicable. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance. The system operates within specific pressure and temperature ranges, adhering to safety standards such as EN 60601-1-2 for electromagnetic compatibility. Sterility and maintenance protocols are outlined in the manufacturer’s instructions to ensure proper functionality and patient safety.
Frequently asked questions
What is the primary purpose of the Vega CPAP System/Heated Humidifier, Model CP-03, and where can it be used?
The Vega CPAP System/Heated Humidifier, Model CP-03, is designed to maintain open airways during sleep by delivering a continuous stream of pressurized air. This helps reduce obstructive sleep apnea events by preventing airway collapse. It is intended for use in both clinical settings, such as hospitals, and home environments for patients requiring long-term therapy.
How is the Vega CPAP System/Heated Humidifier, Model CP-03, supplied, and are there any disposable components?
The system is supplied as a reusable device, but it includes disposable components where applicable. The manufacturer provides specific instructions for maintenance and replacement of these components to ensure proper functionality and patient safety.
Is the Vega CPAP System/Heated Humidifier, Model CP-03, single-use or reusable, and what does this mean for maintenance?
The device itself is reusable, meaning it is designed for repeated use after proper cleaning, maintenance, and sterilization as outlined in the manufacturer’s instructions. This ensures long-term reliability and reduces waste, but it requires adherence to maintenance protocols to maintain performance and hygiene.
What regulatory pathway was followed for FDA clearance of the Vega CPAP System/Heated Humidifier, Model CP-03?
The device received FDA clearance through a 510(k) submission, classified as Substantially Equivalent to a predicate device. The review was conducted by the Anesthesiology (AN) Advisory Committee, and the clearance was granted on June 10, 2011, under the product code BZD (Ventilator, Non-Continuous).
Does the Vega CPAP System/Heated Humidifier, Model CP-03, include a heated humidifier, and how does this benefit the user?
Yes, the system integrates a heated humidifier to condition the air delivered to the patient. This feature improves comfort and compliance by reducing dryness and irritation in the airways, which can occur with standard CPAP therapy. Humidified air helps minimize nasal congestion and throat dryness, enhancing the overall sleep experience.
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: VEGA TECHNOLOGIES CP-03 INSTRUCTION MANUAL Pdf Download, Vega Technologies CP-03 Instruction Manual | Manualzz, Vega Instruction Manual - ManualZilla
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102625 | Class II | Active |
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Manufacturer
- Manufacturer
- Vega Technologies Inc.
- FDA Applicant
- Vega Technologies, Inc.
Sources (1)
- FDA 510(k) K102625 24 fields · synced Sep 20, 2026