FDA 510(k) Application Details - K201620

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K201620
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 US Other 510(k) Applications for this Company
Contact	Yasser Estafanous 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	06/15/2020
Decision Date	01/29/2021
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