FDA 510(k) Application Details - K082657

Device Classification Name	Ventilator, External Body, Negative Pressure, Adult (Cuirass)   More FDA Info for this Device
510(K) Number	K082657
Device Name	Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Applicant	MEDIVENT LIMITED MARYLAND HOUSE, 10 THE DOWNAGE LONDON, ENGLAND NW4 1AA GB Other 510(k) Applications for this Company
Contact	SHAHAR HAYEK 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	09/12/2008
Decision Date	10/08/2008
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	Y
Expedited Review