Company ยท KR
Bionet Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2023. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2023 | K231160 | Cardio Q50, Cardio Q70 Bionet Co., Ltd., KR | DPS |
| Nov 9, 2023 | K231150 | Cardio P1 Bionet Co., Ltd., KR | DPS |
| Nov 15, 2022 | K220535 | Cardio10 Bionet Co., Ltd., KR | DPS |
| Oct 11, 2022 | K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireles Bionet Co., Ltd., KR | IYN |
| Nov 15, 2013 | K130322 | SPM-300 Bionet Co., Ltd. | BZG |
| Jul 16, 2012 | K113306 | CARDIO 7 Bionet Co., Ltd. | DPS |
| Jun 3, 2011 | K102767 | CARDIO XP Bionet Co., Ltd. | DPS |
| Aug 26, 2009 | K090895 | EKG-PLUS II SOFTWARE Bionet Co., Ltd., KR | LOS |
| Dec 11, 2008 | K082008 | BIONET BM3PLUS PATIENT MONITOR Bionet Co., Ltd. | MWI |
| Dec 16, 2005 | K043598 | FC 1400 FETAL MONITOR Bionet Co., Ltd., KR | HGM |
| Dec 16, 2005 | K043597 | FC 700 FETAL MONITOR Bionet Co., Ltd., KR | HGM |
| Mar 3, 2003 | K023082 | BABYCARE Bionet Company, Ltd. | HEP |
| Nov 14, 2002 | K023034 | CARDIOTOUCH-3000 Bionet Company, Ltd. | LOS |
| Nov 21, 2001 | K011328 | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH Bionet Company, Ltd., KR | LOS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||