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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
Recalls CDRH Recalls
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