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FDA 510(k)

MATRx plus

K-Number: K163665 · 2017-05-05

Decision Date2017-05-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MATRx plus is the device name listed in this FDA 510(k) record. The listed applicant is Zephyr Sleep Technologies. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K163665. 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 2017-05-05. The listed applicant is Zephyr Sleep Technologies. The 510(k) number is K163665.

When did MATRx plus receive FDA 510(k) clearance?

MATRx plus received FDA 510(k) clearance on 2017-05-05, under 510(k) number K163665.

Who is the listed applicant for MATRx plus?

The FDA 510(k) record lists Zephyr Sleep Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATRx plus?

The FDA product code for MATRx plus is MNR.

Other records listing Zephyr Sleep Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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