FDA 510(k) Application Details - K042843

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K042843
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD LINTHICUM, MD 21090-1356 US Other 510(k) Applications for this Company
Contact	SANJAY PARIKH 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	10/14/2004
Decision Date	11/12/2004
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