FDA 510(k) Application Details - K073038

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

  More FDA Info for this Device
510(K) Number K073038
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant CAREMATIX INC.
120 S. RIVERSIDE PLAZA
SUITE 2100
CHICAGO, IL 60606 US
Other 510(k) Applications for this Company
Contact SUKHWANT KHANUJA
Other 510(k) Applications for this Contact
Regulation Number 870.2910

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

  More FDA Info for this Product Code
Date Received 10/29/2007
Decision Date 01/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact