I-Sens, Inc.
Medical device manufacturer in Seoul, KR.
27510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring SystemNBW · Special | 08/10/2023SE |
| K222656 | LDE4 Lancing DeviceQRL · Traditional | 11/23/2022SE |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose…NBW · Special | 10/05/2021SE |
| K201551 | KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special | 09/09/2020SE |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring SystemNBW · Special | 01/24/2020SE |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring SystemNBW · Special | 01/17/2020SE |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring SystemNBW · Special | 12/13/2019SE |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…NBW · Special | 11/01/2018SE |
| K180866 | CareSens S Fit Blood Glucose Monitoring SystemNBW · Traditional | 08/31/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | 04/13/2018SE |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW · Special | 12/13/2017SE |
| K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…NBW · Special | 10/19/2017SE |
| K160742 | NoCoding1 Plus Blood Glucose Monitoring SystemNBW · Traditional | 12/16/2016SE |
| K151164 | Assure Prism multi Blood Glucose Monitoring SystemNBW · Special | 08/07/2015SE |
| K133346 | Smartlog Diabetes Management SoftwareNBW · Special | 12/19/2013SE |
| K132288 | Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood…NBW · Special | 11/22/2013SE |
| K130696 | Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose…NBW · Traditional | 08/21/2013SE |
| K131419 | Acura Plus Multi Blood Glucose Monitoring SystemNBW · Special | 08/09/2013SE |
| K121654 | Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control SolutionCGA · Special | 09/05/2012SE |
| K121133 | Caresens N Voice Blood Glucose Monitoring SystemNBW · Special | 07/10/2012SE |
| K120759 | Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose…CGA · Special | 06/05/2012SE |
| K120351 | Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter…NBW · Special | 05/03/2012SE |
| K103278 | Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura…CGA · Special | 10/28/2011SE |
| K103396 | Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control SolutionNBW · Special | 09/27/2011SE |
| K100937 | PC Care Blood Glucose Data Management SoftwareNBW · Traditional | 12/21/2010SE |
| K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…NBW · Special | 02/10/2009SE |
| K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop…NBW · Traditional | 10/17/2008SE |