Curve Positive Airway Pressure System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN170089 FDA 510(k)
- FDA Product Code
- QBY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5273 FDA 510(k)
- Regulation Number
- 868.5273 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Curve Positive Airway Pressure System is a prescription noninvasive ventilatory device designed for the treatment of obstructive sleep apnea. It functions as a positive airway pressure delivery system that provides expiratory positive airway pressure to patients.
This device has received FDA de novo authorization for marketing. It is classified as a class 2 medical device under regulation number 868.5273.
Frequently asked questions
What is the primary function of the Curve Positive Airway Pressure System?
This device is a noninvasive ventilatory system designed for the treatment of obstructive sleep apnea. It functions by delivering expiratory positive airway pressure to the patient to assist with breathing during sleep.
Is the Curve Positive Airway Pressure System available for purchase without a prescription?
No, this is a prescription device. It must be ordered and managed by a healthcare professional to ensure it is appropriate for the patient's specific clinical needs regarding obstructive sleep apnea.
What is the regulatory classification of this device?
The Curve Positive Airway Pressure System is classified as a class 2 medical device under regulation number 868.5273. It has received FDA de novo authorization for marketing under the product code QBY.
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: FRESCA Medical Positive Airway Pressure System for Sleep Apnea, PDF De Novo Classification Request for Curvetm Positive Airway Pressure System, FRESCA Medical's Low Airflow CPAP System for Sleep Apnea Wins FDA Nod
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN170089 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresca Medical
Sources (1)
- FDA 510(k) DEN170089 24 fields · synced Sep 27, 2026