Bionet Co., Ltd.
FDA 510(k) & PMA Approved Devices — 11 products
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Total Devices11
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231160 | Cardio Q50, Cardio Q70 | DPS | 2023-12-15 | View |
| 510(k) | K231150 | Cardio P1 | DPS | 2023-11-09 | View |
| 510(k) | K220535 | Cardio10 | DPS | 2022-11-15 | View |
| 510(k) | 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 | 2022-10-11 | View |
| 510(k) | K130322 | SPM-300 | BZG | 2013-11-15 | View |
| 510(k) | K113306 | CARDIO 7 | DPS | 2012-07-16 | View |
| 510(k) | K102767 | CARDIO XP | DPS | 2011-06-03 | View |
| 510(k) | K090895 | EKG-PLUS II SOFTWARE | LOS | 2009-08-26 | View |
| 510(k) | K082008 | BIONET BM3PLUS PATIENT MONITOR | MWI | 2008-12-11 | View |
| 510(k) | K043598 | FC 1400 FETAL MONITOR | HGM | 2005-12-16 | View |
| 510(k) | K043597 | FC 700 FETAL MONITOR | HGM | 2005-12-16 | View |
No matching devices.
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