The following data is part of a premarket notification filed by Bayer Healthcare Llc with the FDA for Contour Next Ez Blood Glucose Meter.
| Device ID | K130265 |
| 510k Number | K130265 |
| Device Name: | CONTOUR NEXT EZ BLOOD GLUCOSE METER |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE LLC 430 S BEIGER ST Mishawaka, IN 46544 |
| Contact | Jennifer Gregory |
| Correspondent | Jennifer Gregory BAYER HEALTHCARE LLC 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 | 2013-02-04 |
| Decision Date | 2014-06-23 |
| Summary: | summary |