FDA 510(k) Application Details - K122121

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K122121
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	PULSION MEDICAL SYSTEMS SE 1511 ESSEX RD WESTBROOK, CT 06498 US Other 510(k) Applications for this Company
Contact	Jamie Sulley Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2012
Decision Date	08/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review