Identifiers
- 510(k) Number
- K200695 FDA 510(k)
- FDA Product Code
- MNR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
MATRx Plus is classified as a class II ventilatory effort recorder intended for at‑home use to assess respiratory effort and to help identify patients with obstructive sleep apnea who may benefit from oral appliance therapy. The device records ventilatory effort signals and provides data that can be used by clinicians to evaluate suitability for mandibular advancement devices.
The device was cleared by the U.S. Food and Drug Administration through a traditional 510(k) submission (decision date 2020‑08‑24) as substantially equivalent, with product code MNR and registration number 868.2375. It is marketed by Zephyr Sleep Technologies, Inc. and supplied as a medical equipment for home use; the regulatory entry does not specify sterility, single‑use status, or MRI safety.
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: Zephyr Sleep Technologies Ceases Operations, Zephyr Sleep Technologies MATRx plus Healthcare Provider Manual, ZEPHYR MATRX PLUS INSTRUCTIONS MANUAL Pdf Download, Zephyr Sleep Technologies Inc MATRx Plus, MATRx plus - Physician AI Tools
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200695 | Class II | Active |
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Manufacturer
- Manufacturer
- Zephyr Sleep Technologies, Inc.
- FDA Applicant
- Zephyr Sleep Technologies
Sources (1)
- FDA 510(k) K200695 24 fields · synced Sep 23, 2026