FDA 510(k) Application Details - K953175

Device Classification Name	Monitor, St Segment With Alarm   More FDA Info for this Device
510(K) Number	K953175
Device Name	Monitor, St Segment With Alarm
Applicant	DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. TEWKSBURY, MA 01876 US Other 510(k) Applications for this Company
Contact	VINCENT RAUSHER Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MLD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/1995
Decision Date	02/06/1997
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