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FDA 510(k)

Menai System

K-Number: K160836 · 2016-12-15

ApplicantResmed, Ltd.
Decision Date2016-12-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Menai System is a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2016-12-15 under approval number K160836. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Menai System?

Menai System is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Resmed, Ltd.. The 510(k) number is K160836.

When was Menai System approved by the FDA?

Menai System received FDA 510(k) clearance on 2016-12-15, under approval number K160836.

What company makes Menai System?

Menai System is manufactured by Resmed, Ltd..

What is the FDA product code for Menai System?

The FDA product code for Menai System is BZD.

Other Devices by Resmed, Ltd.

K161978AirFit N20 K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV K161487VPAP Adapt SV, VPAP Tx, S9 VPAP Tx K152068Astral 100/150 K153563AirFit F20 K153673AirFit N20

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Related Devices (Code: BZD)

K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, Inc. K153563AirFit F20Resmed, Ltd.

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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