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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K161978
Device Name AirFit N20
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU 2153
Applicant Contact Kim Kuan Lee
Resmed Corp
9001 Spectrum Center Boulevard
San Diego,  CA  92123
Correspondent Contact Miss Sheila Bruschi
Regulation Number868.5905
Classification Product Code
Date Received07/18/2016
Decision Date 11/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls