FDA 510(k) Application Details - K210992

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K210992
Device Name	Valve, Non-Rebreathing
Applicant	Meditera Tibbi Malzeme San Ve TIC AS Ibni Melek OSB Mah, TOSHI Yol 4 Sol. No. 29 Tire Organize sanayi Bolgesi Tire Izmir 35900 TR Other 510(k) Applications for this Company
Contact	Cenk Kilic Kalkan Other 510(k) Applications for this Contact
Regulation Number	868.5870   More FDA Info for this Regulation Number
Classification Product Code	CBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2021
Decision Date	12/23/2021
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