FDA 510(k) Application Details - K050130

Device Classification Name	More FDA Info for this Device
510(K) Number	K050130
Device Name	KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
Applicant	KERBEROS PROXIMAL SOLUTIONS, INC. 10600 NORTH TANTAU AVE. CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	TOM MASON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2005
Decision Date	05/13/2005
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review