FDA 510(k) Application Details - K093081

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K093081
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	MICROBVM SYSTEMS LTD POB 6718 EFRAT 90435 IL Other 510(k) Applications for this Company
Contact	ELI ORBACH 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	10/01/2009
Decision Date	02/05/2010
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