FDA 510(k) Applications Submitted by Jo Won Ju
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180224 |
01/26/2018 |
ELEMENT-TL |
Elemenic Co., Ltd. |
| K172023 |
07/05/2017 |
CELFIRM |
VIOL Co., Ltd. |
| K201551 |
06/09/2020 |
KetoSens BT Blood B-Ketone Monitoring System |
i-SENS, Inc. |
| K170463 |
02/15/2017 |
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System |
i-SENS, Inc. |
| K170614 |
03/01/2017 |
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K160742 |
03/17/2016 |
NoCoding1 Plus Blood Glucose Monitoring System |
i-SENS, INC. |
| K180866 |
04/02/2018 |
CareSens S Fit Blood Glucose Monitoring System |
i-SENS, Inc. |
| K151164 |
05/01/2015 |
Assure Prism multi Blood Glucose Monitoring System |
i-Sens, Inc. |
| K181273 |
05/14/2018 |
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System |
i-SENS, Inc. |
| K171480 |
05/19/2017 |
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System |
i-SENS, Inc. |
| K201394 |
05/27/2020 |
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K192220 |
08/15/2019 |
ReliOn Premier Classic Blood Glucose Monitoring System |
i-SENS, Inc. |
| K192859 |
10/04/2019 |
CareSens S Clear BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K193590 |
12/23/2019 |
CareSens S Fit BT Blood Glucose Monitoring System |
i-SENS, Inc. |
| K962107 |
05/31/1996 |
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 |
LEONACHI, INC. |
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