The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Acura Plus Multi Blood Glucose Monitoring System.
| Device ID | K131419 |
| 510k Number | K131419 |
| Device Name: | ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul, KR 139-845 |
| Contact | Chae Yun Lim |
| Correspondent | Chae Yun Lim i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul, KR 139-845 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2013-08-09 |
| Summary: | summary |