FDA 510(k) Application Details - K992323

Device Classification Name	Monitor, St Segment With Alarm   More FDA Info for this Device
510(K) Number	K992323
Device Name	Monitor, St Segment With Alarm
Applicant	DATEX-OHMEDA, INC. 3 HIGHWOOD DR. TEWKSBURY, MA 01876 US Other 510(k) Applications for this Company
Contact	JOEL C KENT 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	07/12/1999
Decision Date	11/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review