FDA 510(k) Applications for Medical Device Product Code "KRE"
(Analyzer, Pacemaker Generator Function, Indirect)

FDA 510(k) Number Applicant Device Name Decision Date
K072950 CYGNUS, LLC CYGNUS 12 LEAD ECG MODULE 08/22/2008
K032926 MEDTRONIC VASCULAR EKG SPEAKS 10/15/2003
K110693 MEDTRONIC, INC. PACEART OPTIMA SYSTEM SOFTWARE 06/08/2011


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