Respironics Custom II Oral Appliance
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033823 FDA 510(k)
- FDA Product Code
- LRK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Respironics Custom II Oral Appliance is an anti-snoring device. It is designed to be worn in the mouth to assist in the management of snoring.
This device is authorized under FDA 510(k) clearance K033823. It is classified under regulation number 872.5570 within the dental specialty.
Frequently asked questions
What is the primary purpose of the Respironics Custom II Oral Appliance?
This device is specifically designed to be worn in the mouth to assist in the management of snoring.
Is this device authorized for use?
Yes, the Respironics Custom II Oral Appliance is authorized under FDA 510(k) clearance K033823.
How is this device classified?
The device is classified under regulation number 872.5570 within the dental specialty.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033823 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K033823 24 fields · synced Sep 23, 2026