Bionet Co., Ltd.
Anyang-si Gyeonggi, KR
BIONET CO., LTD. appears in FDA device records in Anyang-si Gyeonggi, KR. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Bionet Co., Ltd. between 2001 and 2023. The busiest year on record is 2005, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231160 | Cardio Q50, Cardio Q70 | DPS | Substantially Equivalent | |
| K231150 | Cardio P1 | DPS | Substantially Equivalent | |
| K220535 | Cardio10 | DPS | Substantially Equivalent | |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | IYN | Substantially Equivalent | |
| K130322 | SPM-300 | BZG | Substantially Equivalent | |
| K113306 | CARDIO 7 | DPS | Substantially Equivalent | |
| K102767 | CARDIO XP | DPS | Substantially Equivalent | |
| K090895 | EKG-PLUS II SOFTWARE | LOS | Substantially Equivalent | |
| K082008 | BIONET BM3PLUS PATIENT MONITOR | MWI | Substantially Equivalent | |
| K043598 | FC 1400 FETAL MONITOR | HGM | Substantially Equivalent | |
| K043597 | FC 700 FETAL MONITOR | HGM | Substantially Equivalent | |
| K023082 | BABYCARE | HEP | Substantially Equivalent | |
| K023034 | CARDIOTOUCH-3000 | LOS | Substantially Equivalent | |
| K011328 | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH | LOS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003681187 | 3003681187 | BIONET CO., LTD. | 401, 34, LS-ro 91beon-gil, Dongan-gu, Anyang-si Gyeonggi 14119 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DPSElectrocardiograph
- HEPMonitor, Blood-Flow, Ultrasonic
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- BZGSpirometer, Diagnostic
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain