Identifiers
- 510(k) Number
- K192624 FDA 510(k)
- FDA Product Code
- OLV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ApneaTrak is a home sleep apnea testing device used to diagnose and monitor sleep disordered breathing, including obstructive sleep apnea, central sleep apnea, and hypoventilation. It collects data on breathing and snoring patterns during sleep. The device is available in three models: Core, Legacy, and TST.
The ApneaTrak is supplied for home use and is a Class II medical device with FDA 510(k) clearance. It is authorized for use in neurology applications and is regulated under product code OLV. The device is not specified as single-use or reusable, and no information regarding MRI safety or storage conditions is provided.
Frequently asked questions
What is the ApneaTrak device used for?
The ApneaTrak is a home sleep apnea testing device designed to diagnose and monitor sleep disordered breathing, including obstructive sleep apnea, central sleep apnea, and hypoventilation. It collects data on breathing and snoring patterns during sleep.
What models of ApneaTrak are available?
The ApneaTrak is available in three models: Core, Legacy, and TST. Each model is designed for home use to diagnose and monitor sleep disordered breathing patterns.
Is the ApneaTrak a single-use or reusable device?
The device is not specified as single-use or reusable in the provided information. It is a Class II medical device with FDA 510(k) clearance for home use in diagnosing sleep disordered breathing.
What is the regulatory status of the ApneaTrak?
The ApneaTrak is a Class II medical device with FDA 510(k) clearance, authorized for use in neurology applications and regulated under product code OLV. It received FDA clearance on February 20, 2020.
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: Home Sleep Testing (HSAT) Devices | Cadwell ApneaTrak, Patient Instruction Videos for ApneaTrak Core with Disposables - Cadwell, PDF ApneaTrak:Core Patient Guide - cadwell.support
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192624 | Class II | Active |
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Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (1)
- FDA 510(k) K192624 24 fields · synced Oct 6, 2026