FDA 510(k) Application Details - K991886

Device Classification Name	Probe, Thermodilution   More FDA Info for this Device
510(K) Number	K991886
Device Name	Probe, Thermodilution
Applicant	PULSION MEDICAL SYSTEMS, INC. 8911 SEDGLEY DR. WILMINGTON, NC 28412 US Other 510(k) Applications for this Company
Contact	ULF BORG Other 510(k) Applications for this Contact
Regulation Number	870.1915   More FDA Info for this Regulation Number
Classification Product Code	KRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/1999
Decision Date	05/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review