Devices · Zephyr Sleep Technologies

MATRx plus

Zephyr Sleep Technologies is listed for MATRx plus (DEN170090). The FDA list gives August 23, 2018 as the date of the final decision. The lead panel is Dental, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QCJ as “Closed Loop Auto Titration Device For Oral Appliances”: A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170090

Official FDA database record

Date of final decision

August 23, 2018

Company on the FDA list

Zephyr Sleep Technologies

Lead panel

Dental

Primary product code

QCJ

openFDA device name for the code

Closed Loop Auto Titration Device For Oral Appliances

Device class

2

Regulation number

872.5571

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned