FDA 510(k) Application Details - K141756

Device Classification Name System,Network And Communication,Physiological Monitors

  More FDA Info for this Device
510(K) Number K141756
Device Name System,Network And Communication,Physiological Monitors
Applicant Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER, MA 01810 US
Other 510(k) Applications for this Company
Contact KAREN PROVENCHER
Other 510(k) Applications for this Contact
Regulation Number 870.2300

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

  More FDA Info for this Product Code
Date Received 06/30/2014
Decision Date 12/12/2014
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