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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 K170924
Device Name AirFit F20
Applicant
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU 2153
Applicant Contact Johanna Wright
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 Received03/29/2017
Decision Date 01/03/2018
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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