Medical Device Manufacturer · KR , Wonju, Kwangwon-Do

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

11 submissions · 11 cleared · Since 2005

11

Total

11

Cleared

0

Denied

FDA 510(k) cleared devices by Bionet Co., Ltd. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Dec 15, 2023

Cardio Q50, Cardio Q70

Cardiovascular · 238d

Cleared Nov 09, 2023

Cardiovascular · 202d

Cleared Nov 15, 2022

Cardiovascular · 264d

Cleared Jul 16, 2012

Cardiovascular · 250d

Cleared Jun 03, 2011

Cardiovascular · 252d

Cleared Aug 26, 2009

EKG-PLUS II SOFTWARE

Cardiovascular · 149d

Cleared Dec 11, 2008

BIONET BM3PLUS PATIENT MONITOR

Cardiovascular · 149d