Data / Medical devices / South Korea / Bionet Co., Ltd.
Bionet Co., Ltd.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 15 510(k) clearances
Bionet Co., Ltd. is registered with the FDA (registration 3003681187) in Anyang-si Gyeonggi, South Korea. It lists 9 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003681187
- Address
- 401, 34, LS-ro 91beon-gil, Dongan-gu, Anyang-si Gyeonggi, South Korea, 14119
- Owner or operator
- Bionet Co., Ltd. (9052948)
- Roles
- Manufacturer
- First device listed
- June 30, 2006
- Registered through
- 2026
- Brand names listed
- BM3, BM3 Plus, BMS Plus, BabyCare, Cardio P1, Cardio Q50, Cardio Q70, Cardio10 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| LOS | LOS | Manufacturer | accessdata.fda.gov | |
| Monitor, Blood-Flow, Ultrasonic | HEP | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 15, 2023 | K231160 | Cardio Q50, Cardio Q70 | DPS | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| November 9, 2023 | K231150 | Cardio P1 | DPS | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| November 15, 2022 | K220535 | Cardio10 | DPS | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| October 11, 2022 | 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 | Bionet Co., Ltd. | accessdata.fda.gov |
| December 4, 2013 | K132033 | BM3/BM3 PLUS | MWI | Substantially Equivalent | Noblitt & Rueland | accessdata.fda.gov |
| November 15, 2013 | K130322 | SPM-300 | BZG | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| July 16, 2012 | K113306 | CARDIO 7 | DPS | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| June 3, 2011 | K102767 | CARDIO XP | DPS | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| August 26, 2009 | K090895 | EKG-PLUS II SOFTWARE | LOS | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| December 11, 2008 | K082008 | BIONET BM3PLUS PATIENT MONITOR | MWI | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| December 16, 2005 | K043598 | FC 1400 FETAL MONITOR | HGM | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| December 16, 2005 | K043597 | FC 700 FETAL MONITOR | HGM | Substantially Equivalent | Bionet Co., Ltd. | accessdata.fda.gov |
| March 3, 2003 | K023082 | BABYCARE | HEP | Substantially Equivalent | Bionet Company, Ltd. | accessdata.fda.gov |
| November 14, 2002 | K023034 | CARDIOTOUCH-3000 | LOS | Substantially Equivalent | Bionet Company, Ltd. | accessdata.fda.gov |
| November 21, 2001 | K011328 | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | Bionet Company, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of Spirometer, Diagnostic
- All makers of System, Monitoring, Perinatal
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Monitor, Blood-Flow, Ultrasonic
- All makers of LOS
Updated December 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.