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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 K203126
Device Name S10 Kirra
ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU 2053
Applicant Contact Peter Jennings
ResMed Corp
9001 Spectrum Center Boulevard
San Diego,  CA  92123
Correspondent Contact Sheila Bruschi
Regulation Number868.5905
Classification Product Code
Date Received10/19/2020
Decision Date 12/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No