FDA 510(k) Application Details - K212905

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K212905
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	Safe BVM Corporation 1120 Weidman Road Chesterfield, MO 63017 US Other 510(k) Applications for this Company
Contact	Haris Shekhani Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2021
Decision Date	08/18/2022
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