FDA 510(k) Application Details - K201666

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K201666
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	Flexicare Medical Limited Cynon Valley Business Park Mountain Ash cf45 4er GB Other 510(k) Applications for this Company
Contact	Joel Biddle Other 510(k) Applications for this Contact
Regulation Number	868.2600   More FDA Info for this Regulation Number
Classification Product Code	CAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2020
Decision Date	11/13/2020
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