Medical Device Manufacturer · US , Walker , MI

Suzuken Co., Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1981

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Suzuken Co., Ltd. Cardiovascular ✕

11 devices

1-11 of 11

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

Cardiovascular · 67d

Cleared Aug 13, 1981

Cardiovascular · 37d

Cleared Aug 13, 1981

Cardiovascular · 37d