FDA 510(k) Applications Submitted by Bionet Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220169 |
01/20/2022 |
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) |
Bionet Co., Ltd. |
| K090895 |
03/30/2009 |
EKG-PLUS II SOFTWARE |
BIONET CO., LTD. |
| K220535 |
02/24/2022 |
Cardio10 |
Bionet Co., Ltd. |
| K231150 |
04/21/2023 |
Cardio P1 |
Bionet Co., Ltd. |
| K231160 |
04/21/2023 |
Cardio Q50, Cardio Q70 |
Bionet Co., Ltd. |
| K130322 |
02/08/2013 |
SPM-300 |
BIONET CO., LTD. |
| K102767 |
09/24/2010 |
CARDIO XP |
BIONET CO., LTD. |
| K113306 |
11/09/2011 |
CARDIO 7 |
BIONET CO., LTD. |
| K043597 |
12/29/2004 |
FC 700 FETAL MONITOR |
BIONET CO., LTD. |
| K043598 |
12/29/2004 |
FC 1400 FETAL MONITOR |
BIONET CO., LTD. |
| K082008 |
07/15/2008 |
BIONET BM3PLUS PATIENT MONITOR |
BIONET CO., LTD. |
|
|
