FDA 510(k) Application Details - K091461

Device Classification Name	Accessory To Continuous Ventilator (Respirator)   More FDA Info for this Device
510(K) Number	K091461
Device Name	Accessory To Continuous Ventilator (Respirator)
Applicant	CARDIOPULMONARY CORP. 200 CASCADE BLVD. MILFORD, CT 06460 US Other 510(k) Applications for this Company
Contact	JORDAN SCHRECK Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2009
Decision Date	08/14/2009
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