FDA 510(k) Application Details - K153387

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K153387
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	3B MEDICAL, INC. 21301 HWY 27 LAKE WALES, FL 33859 US Other 510(k) Applications for this Company
Contact	ALEX LUCIO 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	11/23/2015
Decision Date	09/08/2016
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