The following data is part of a premarket notification filed by Ascensia Diabetes Care Us Inc. with the FDA for Contour Next Ez Blood Glucose Monitoring System.
| Device ID | K162336 |
| 510k Number | K162336 |
| Device Name: | Contour Next EZ Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Ascensia Diabetes Care US Inc. 430 South Beiger Street Mishawaka, IN 46544 |
| Contact | Jennifer L. Gregory |
| Correspondent | Jennifer L. Gregory Ascensia Diabetes Care US Inc. 430 South Beiger Street Mishawaka, IN 46544 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2017-01-12 |
| Summary: | summary |