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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, breathing frequency
510(k) Number K200445
Device Name The C100 Contactless Breathing Monitor
Circadia Technologies Ltd.
6 Delmey Close
Croydon,  GB CR0 5QD
Applicant Contact Michal Maslik
Rook Quality Systems, Inc.
1155 Mount Vernon Highway, Suite 800
Dunwoody,  GA  30338
Correspondent Contact Andrew Wu
Regulation Number868.2375
Classification Product Code
Date Received02/24/2020
Decision Date 06/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No