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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 K171212
Device Name AirFit N20
Applicant
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU 2153
Applicant Contact Kim Kuan LEE
Correspondent
ResMed Corp (Registration Number: 3007573469)
9001 Spectrum Center Boulevard
San Diego,  CA  92123
Correspondent Contact Sheila Bruschi
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/25/2017
Decision Date 09/28/2017
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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