Devices · Zephyr Sleep Technologies

MATRx plus

Zephyr Sleep Technologies is listed for MATRx plus (K163665). The FDA list gives May 5, 2017 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MNR. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” 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/pmn.cfm?ID=K163665

Official FDA database record

Date of final decision

May 5, 2017

Company on the FDA list

Zephyr Sleep Technologies

Lead panel

Anesthesiology

Primary product code

MNR

openFDA device name for the code

Ventilatory Effort Recorder

Device class

2

Regulation number

868.2375

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary