Suzuken Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Kenz Cardico1211, KENZ CARDY302 MAX, DISPOSAL ECG ELECTRODES, MODEL EASYRODE
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suzuken Co., Ltd. Cardiovascular ✕
11 devices
Cleared
Jun 01, 2018
Kenz Cardico1211
Cardiovascular
329d
Cleared
Jan 06, 2011
KENZ CARDY302 MAX
Cardiovascular
268d
Cleared
Oct 13, 2009
DISPOSAL ECG ELECTRODES, MODEL EASYRODE
Cardiovascular
69d
Cleared
Jan 08, 2001
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS
Cardiovascular
201d
Cleared
Jul 01, 1987
KENZ-CARDICO 1201
Cardiovascular
148d
Cleared
Aug 06, 1986
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH
Cardiovascular
34d
Cleared
Jul 11, 1985
KENZ 80Z MARK II
Cardiovascular
290d
Cleared
Dec 15, 1982
ELECTROCARDIOGRAPH INTERPRETER
Cardiovascular
69d
Cleared
Jun 01, 1982
KENZ-45M
Cardiovascular
67d
Cleared
Aug 13, 1981
KENL-ECG-3
Cardiovascular
37d
Cleared
Aug 13, 1981
KENL-ECG
Cardiovascular
37d