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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K213360
Device Name SleepCheckRx
Applicant
ResApp Health
Level 12, 100 Creek Street
Brisbane,  AU 4000
Applicant Contact Neroli Anderson
Correspondent
ResApp Health
Level 12, 100 Creek Street
Brisbane,  AU 4000
Correspondent Contact Neroli Anderson
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/12/2021
Decision Date 07/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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