FDA 510(k) Application Details - K952054

Device Classification Name Detector And Alarm, Arrhythmia

  More FDA Info for this Device
510(K) Number K952054
Device Name Detector And Alarm, Arrhythmia
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact THOMAS CONNELLY
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 05/01/1995
Decision Date 06/07/1996
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