FDA 510(k) Application Details - K103434

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K103434
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	3B PRODUCTS, LLC 1142 N SCENIC HIGHWAY LAKE WALES, FL 33853 US Other 510(k) Applications for this Company
Contact	ALBERT ALEXANDER 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	11/23/2010
Decision Date	10/13/2011
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