KRE · Class II · 21 CFR 870.3640

FDA Product Code KRE: Analyzer, Pacemaker Generator Function, Indirect

Leading manufacturers include Medtronic Vascular and Medtronic, Inc..

13
Total
13
Cleared
116d
Avg days
1980
Since

FDA 510(k) Cleared Analyzer, Pacemaker Generator Function, Indirect Devices (Product Code KRE)

13 devices
1–13 of 13
Cleared Jun 08, 2011
PACEART OPTIMA SYSTEM SOFTWARE
K110693
Medtronic, Inc.
Cardiovascular · 89d
Cleared Oct 15, 2003
EKG SPEAKS
K032926
Medtronic Vascular
Cardiovascular · 23d

About Product Code KRE - Regulatory Context