The following data is part of a premarket notification filed by Ascensia Diabetes Care with the FDA for Contour Next One Blood Glucose Monitoring System.
| Device ID | K160682 |
| 510k Number | K160682 |
| Device Name: | CONTOUR NEXT ONE Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ASCENSIA DIABETES CARE 430 S. BEIGER ST. Mishawaka, IN 46544 |
| Contact | Roger Sonnenburg |
| Correspondent | Jennifer Gregory ASCENSIA DIABETES CARE 430 S. BEIGER ST. Mishawaka, IN 46544 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-10 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301939767018 | K160682 | 000 |
| 40301939765014 | K160682 | 000 |
| 40301939763010 | K160682 | 000 |
| 40301937824010 | K160682 | 000 |
| 00301937818011 | K160682 | 000 |
| 40301939766011 | K160682 | 000 |