FDA 510(k) Application Details - K060756

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

  More FDA Info for this Device
510(K) Number K060756
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH
MARTINISTRASSE 52
PAVILLON 41A (UKE)
HAMBURG D-20251 DE
Other 510(k) Applications for this Company
Contact ANGELIKA M BERGER
Other 510(k) Applications for this Contact
Regulation Number 870.2300

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

  More FDA Info for this Product Code
Date Received 03/21/2006
Decision Date 10/30/2006
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