FDA 510(k) Application Details - K974492

Device Classification Name Monitor, St Segment With Alarm

  More FDA Info for this Device
510(K) Number K974492
Device Name Monitor, St Segment With Alarm
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact JACQUELINE E M. EMERY
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 11/28/1997
Decision Date 02/26/1998
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact