FDA 510(k) Application Details - K072295

Device Classification Name Oximeter

  More FDA Info for this Device
510(K) Number K072295
Device Name Oximeter
Applicant ORIDION CAPNOGRAPHY, INC.
HAMARPE 7
JERUSALEM 91450 IL
Other 510(k) Applications for this Company
Contact RACHEL WEISSBROD
Other 510(k) Applications for this Contact
Regulation Number 870.2700

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

  More FDA Info for this Product Code
Date Received 08/16/2007
Decision Date 10/11/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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