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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 K153563
Device Name AirFit F20
Applicant
Resmed, Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Applicant Contact Johanna Wright
Correspondent
ResMed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact Larissa D'Andrea
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/14/2015
Decision Date 05/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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