FDA 510(k) Application Details - K112852

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K112852
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	THOMAS C LOESCHER 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	10/18/2011
Decision Date	01/13/2012
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