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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 Dr.
Bella Vista Nsw 2153,  AU 2153
Applicant Contact Kim Kuan LEE
Correspondent
Resmed Corp (Registration Number: 3007573469)
9001 Spectrum Center Blvd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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