The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose Monitoring System.
| Device ID | K130696 |
| 510k Number | K130696 |
| Device Name: | CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul, Korea, KR 139-845 |
| Contact | Chae Yun Lim |
| Correspondent | Chae Yun Lim i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul, Korea, KR 139-845 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-14 |
| Decision Date | 2013-08-21 |
| Summary: | summary |