FDA 510(k) Application Details - K031395

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K031395
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	MERLIN MEDICAL LIMITED THE WHITBREAD CENTRE,RHYMNEY, GWENT UNITED KINGDOM NP22 5BF GB Other 510(k) Applications for this Company
Contact	ROGERT STEELE 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	05/02/2003
Decision Date	07/16/2004
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