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FDA 510(k)

AirFit N20

K-Number: K161978 · 2016-11-17

ApplicantResmed, Ltd.
Decision Date2016-11-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirFit N20 is a medical device manufactured by Resmed, Ltd.. It received FDA 510(k) clearance on 2016-11-17 under approval number K161978. 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 AirFit N20?

AirFit N20 is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Resmed, Ltd.. The 510(k) number is K161978.

When was AirFit N20 approved by the FDA?

AirFit N20 received FDA 510(k) clearance on 2016-11-17, under approval number K161978.

What company makes AirFit N20?

AirFit N20 is manufactured by Resmed, Ltd..

What is the FDA product code for AirFit N20?

The FDA product code for AirFit N20 is BZD.

Other Devices by Resmed, Ltd.

K160836Menai System 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)

K160836Menai SystemResmed, 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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