FDA 510(k) Application Details - K242769

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K242769
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	Draegerwerk AG & Co. KGaA Moislinger Allee 53-55 Luebeck 23542 DE Other 510(k) Applications for this Company
Contact	Jan Upmeier Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2024
Decision Date	04/04/2025
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