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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 K153673
Device Name AirFit N20
Applicant
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU 2153
Applicant Contact Kim Kuan Lee
Correspondent
Resmed Corp
9001 Spectrum Center Boulevard
San Diego,  CA  92123
Correspondent Contact Larissa D'Andrea
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/21/2015
Decision Date 05/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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