Medical Device Manufacturer · KR , Wonju, Kwangwon-Do

Bionet Co., Ltd.

11 submissions · 11 cleared · Since 2005
11
Total
11
Cleared
0
Denied

Bionet Co., Ltd. — FDA 510(k) Submissions

Bionet Co., Ltd. has submitted 11 FDA 510(k) premarket notifications since 2005, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrocardiograph, System, Monitoring, Perinatal, Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms), LOS, Spirometer, Diagnostic . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Cardio Q50, Cardio Q70
K231160 · DPS Electrocardiograph · Cardiovascular
Dec 2023 238d
Cardio P1
K231150 · DPS Electrocardiograph · Cardiovascular
Nov 2023 202d
Cardio10
K220535 · DPS Electrocardiograph · Cardiovascular
Nov 2022 264d
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
K220169 · IYN System, Imaging, Pulsed... · Radiology
Oct 2022 264d
SPM-300
K130322 · BZG Spirometer, Diagnostic · Anesthesiology
Nov 2013 280d
CARDIO 7
K113306 · DPS Electrocardiograph · Cardiovascular
Jul 2012 250d
CARDIO XP
K102767 · DPS Electrocardiograph · Cardiovascular
Jun 2011 252d
EKG-PLUS II SOFTWARE
K090895 · LOS · Cardiovascular
Aug 2009 149d
BIONET BM3PLUS PATIENT MONITOR
K082008 · MWI Monitor, Physiological,... · Cardiovascular
Dec 2008 149d
FC 700 FETAL MONITOR
K043597 · HGM System, Monitoring,... · Obstetrics & Gynecology
Dec 2005 352d
FC 1400 FETAL MONITOR
K043598 · HGM System, Monitoring,... · Obstetrics & Gynecology
Dec 2005 352d
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