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FDA 510(k)

MATRx Plus

K-Number: K191925 · 2019-10-29

ApplicantZephyr Sleep Technologies
Decision Date2019-10-29
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MATRx Plus is a medical device manufactured by Zephyr Sleep Technologies. It received FDA 510(k) clearance on 2019-10-29 under approval number K191925. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATRx Plus?

MATRx Plus is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Zephyr Sleep Technologies. The 510(k) number is K191925.

When was MATRx Plus approved by the FDA?

MATRx Plus received FDA 510(k) clearance on 2019-10-29, under approval number K191925.

What company makes MATRx Plus?

MATRx Plus is manufactured by Zephyr Sleep Technologies.

What is the FDA product code for MATRx Plus?

The FDA product code for MATRx Plus is MNR.

Other Devices by Zephyr Sleep Technologies

K163665MATRx plus K181996MATRx Plus DEN170090MATRx plus K200695MATRx plus

Related Devices (Code: MNR)

K153070Watch-PAT200UItamar Medical , Ltd. K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalSalter Labs K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. K163696SleepImage SystemMycardio, LLC Dba Sleepimage. K163665MATRx plusZephyr Sleep Technologies K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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