1 device · 1 company · 2018
Product code QCJ: Closed Loop Auto Titration Device For Oral Appliances
1 device under product code QCJ, 2018, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Closed Loop Auto Titration Device For Oral Appliances. 21 CFR 872.5571, Class II. A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patients respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| MATRx plusDEN170090 · De Novo | Zephyr Sleep Technologies | Dental | database entry |
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