FDA 510(k) Application Details - K961165

Device Classification Name Detector And Alarm, Arrhythmia

  More FDA Info for this Device
510(K) Number K961165
Device Name Detector And Alarm, Arrhythmia
Applicant HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
Other 510(k) Applications for this Company
Contact RAY STERLING
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 03/25/1996
Decision Date 10/10/1996
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