The following data is part of a premarket notification filed by Labstyle Innovations, Ltd. with the FDA for Dario Blood Glucose Monitoring System.
| Device ID | K163159 |
| 510k Number | K163159 |
| Device Name: | Dario Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LabStyle Innovations, Ltd. 9 Halamish Street, North Industrial Park Caesarea, IL 3890000 |
| Contact | Erez Raphael |
| Correspondent | Tracey Wielinski Qualtra Consulting, Inc. 5 Casie Lane Pepperell, MA 01463 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2017-07-19 |
| Summary: | summary |