FDA 510(k) Application Details - K200445

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K200445
Device Name	Monitor, Breathing Frequency
Applicant	Circadia Technologies Ltd. 6 Delmey Close Croydon CR0 5QD GB Other 510(k) Applications for this Company
Contact	Michal Maslik Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2020
Decision Date	06/24/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review