FDA 510(k) Application Details - K072290

Device Classification Name	Ventilator, External Body, Negative Pressure, Adult (Cuirass)   More FDA Info for this Device
510(K) Number	K072290
Device Name	Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Applicant	DIMA ITALIA SRL 4655 KIRKWOOD CT. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LEWIS WARD Other 510(k) Applications for this Contact
Regulation Number	868.5935   More FDA Info for this Regulation Number
Classification Product Code	BYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2007
Decision Date	05/29/2008
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