FDA 510(k) Application Details - K242935

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K242935
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	BMC Medical Co., Ltd. Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road Fengtai District Beijing 100073 CN Other 510(k) Applications for this Company
Contact	Amy Wang Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	01/15/2025
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