KRE · Class II · 21 CFR 870.3640

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

Leading manufacturers include Instromedix, Inc., Medtronic Vascular and Cygnus, LLC.

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 Aug 22, 2008
CYGNUS 12 LEAD ECG MODULE
K072950
Cygnus, LLC
Cardiovascular · 309d
Cleared Oct 15, 2003
EKG SPEAKS
K032926
Medtronic Vascular
Cardiovascular · 23d
Cleared Mar 18, 1993
HPM 40 HEART PACEMAKER MONITOR
K922742
Biotronik, GmbH & Co.
Cardiovascular · 283d
Cleared Dec 16, 1983
PACEMAKER SYS ANALYZER #384
K833647
Pacesetter Systems
Cardiovascular · 60d
Cleared Nov 14, 1983
PACEMAKER SYS. ANALYZER 378
K832959
Siemens Elema AB
Cardiovascular · 76d
Cleared Mar 17, 1981
CARDIOMEMO
K803286
Instromedix, Inc.
Cardiovascular · 77d
Cleared Aug 14, 1980
ELECTRONIC PACEMAKER WAVEFORM ANALYZER
K800696
Instromedix, Inc.
Cardiovascular · 139d

About Product Code KRE - Regulatory Context