FDA 510(k) Application Details - K094003

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K094003
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	HERSILL, S.L. PUERTO DE NAVACERRADA, 3 MOSTOLES ( MADRID) 28935 ES Other 510(k) Applications for this Company
Contact	ANA MARIA ROMERO 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	12/28/2009
Decision Date	09/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review