The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Glucofacts Express Diabetes Management Software.
| Device ID | K082486 |
| 510k Number | K082486 |
| Device Name: | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. Mishawaka, IN 46544 |
| Contact | Roger Sonnenburg |
| Correspondent | Roger Sonnenburg BAYER HEALTHCARE, LLC 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 | 2008-08-28 |
| Decision Date | 2008-10-08 |
| Summary: | summary |