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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 the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) 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. The listed applicant is Resmed, Ltd.. The 510(k) number is K161978.

When did AirFit N20 receive FDA 510(k) clearance?

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

Who is the listed applicant for AirFit N20?

The FDA 510(k) record lists Resmed, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirFit N20?

The FDA product code for AirFit N20 is BZD.

Related Clinical Trials

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Other records listing Resmed, Ltd. 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.

K253553OrionK254104ResScan EssentialsK251889myAirK251657Personalized Therapy Comfort Settings (PTCS)K250624myAirK241939EasyCare Tx 2

View all 22 devices →

Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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