510(k) K200445

The C100 Contactless Breathing Monitor by Circadia Technologies, Ltd. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2020
Date Received
February 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type