Dental · De Novo · 2018
MATRx plus
Zephyr Sleep Technologies. Granted by FDA on 23 August 2018 under submission DEN170090, product code QCJ (closed loop auto titration device for oral appliances). What FDA's record says, in FDA's words.
Device record · DEN170090
- Device. MATRx plusDEVICE
- Company. Zephyr Sleep TechnologiesCOMPANY
- Decision. 23 August 2018, De NovoDECISION
- Panel. DentalPANEL
- Product code. QCJ, Closed Loop Auto Titration Device For Oral AppliancesCODE
- Regulation. 21 CFR 872.5571, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. MATRx plus uses these recordings to produce a report for the HCP that can 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. The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QCJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QCJ, in Dental, from Zephyr Sleep Technologies, or granted in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.