FDA 510(k) Application Details - K024213

Device Classification Name Detector And Alarm, Arrhythmia

  More FDA Info for this Device
510(K) Number K024213
Device Name Detector And Alarm, Arrhythmia
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 S. WOOD AVENUE
ISELIN, NJ 08830 US
Other 510(k) Applications for this Company
Contact JAMIE YIEH
Other 510(k) Applications for this Contact
Regulation Number 870.1025

  More FDA Info for this Regulation Number
Classification Product Code DSI
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/20/2002
Decision Date 03/23/2004
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