The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Usb Blood Glucose Monitoring System.
| Device ID | K121087 |
| 510k Number | K121087 |
| Device Name: | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE 430 SOUTH BEIGER ST. Mishawaka, IN 46544 |
| Contact | Roger Sonnenburg |
| Correspondent | Roger Sonnenburg BAYER HEALTHCARE 430 SOUTH BEIGER ST. 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 | 2012-04-10 |
| Decision Date | 2012-06-28 |
| Summary: | summary |