FDA 510(k) Application Details - K131765

Device Classification Name Plethysmograph, Impedance

  More FDA Info for this Device
510(K) Number K131765
Device Name Plethysmograph, Impedance
Applicant CONMED CORPORATION
525 FRENCH RD.
UTICA, NY 13502 US
Other 510(k) Applications for this Company
Contact LISA ANDERSON
Other 510(k) Applications for this Contact
Regulation Number 870.2770

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

  More FDA Info for this Product Code
Date Received 06/17/2013
Decision Date 12/20/2013
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