FDA 510(k) Application Details - K954501

Device Classification Name	Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K954501
Device Name	Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Applicant	MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	THOMAS K JOHNSEN Other 510(k) Applications for this Contact
Regulation Number	870.4410   More FDA Info for this Regulation Number
Classification Product Code	DTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/1995
Decision Date	01/16/1996
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