The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Ascensia Brio Blood Glucose Monitoring System.
| Device ID | K043158 |
| 510k Number | K043158 |
| Device Name: | ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE, LLC 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -2004 |
| Contact | George M Tancos |
| Correspondent | George M Tancos BAYER HEALTHCARE, LLC 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -2004 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2004-12-22 |
| Summary: | summary |