FDA 510(k) Application Details - K112783

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K112783
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	VBM MEDIZINTECHNIK GMBH 1, EINSTEINSTRASSE SULZ AM NECKAR, BADEN-WURTTEMBERG 72172 DE Other 510(k) Applications for this Company
Contact	ANKE BLOCHER Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2011
Decision Date	12/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review