The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080.
| Device ID | K060470 |
| 510k Number | K060470 |
| Device Name: | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Contact | Roger Sonnemburg |
| Correspondent | Roger Sonnemburg BAYER HEALTHCARE 430 SOUTH BEIGER STREET 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 | 2006-02-23 |
| Decision Date | 2006-04-12 |
| Summary: | summary |