The C100 Contactless Breathing Monitor

Monitor, Breathing Frequency

Circadia Technologies Ltd.

The following data is part of a premarket notification filed by Circadia Technologies Ltd. with the FDA for The C100 Contactless Breathing Monitor.

Pre-market Notification Details

Device IDK200445
510k NumberK200445
Device Name:The C100 Contactless Breathing Monitor
ClassificationMonitor, Breathing Frequency
Applicant Circadia Technologies Ltd. 6 Delmey Close Croydon,  GB Cr0 5qd
ContactMichal Maslik
CorrespondentAndrew Wu
Rook Quality Systems, Inc. 1155 Mount Vernon Highway, Suite 800 Dunwoody,  GA  30338
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-06-24

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