FDA 510(k) Application Details - K993826

Device Classification Name	Monitor, St Segment   More FDA Info for this Device
510(K) Number	K993826
Device Name	Monitor, St Segment
Applicant	DRAEGER MEDICAL, INC. 3135 QUARRY RD. TELFORD, PA 18969 US Other 510(k) Applications for this Company
Contact	GALE E WINARSKY Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	MLC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1999
Decision Date	03/23/2000
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