The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Ascensia Breeze 2 Blood Glucose Monitoring System.
| Device ID | K062347 |
| 510k Number | K062347 |
| Device Name: | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. Mishawaka, IN 46544 |
| Contact | Marc Henn |
| Correspondent | Marc Henn BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. Mishawaka, IN 46544 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-10 |
| Decision Date | 2006-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301931468500 | K062347 | 000 |
| 40301931467503 | K062347 | 000 |
| 00301931466218 | K062347 | 000 |
| 40301931465509 | K062347 | 000 |
| 50301931491017 | K062347 | 000 |
| 50301931490010 | K062347 | 000 |
| 50301931489014 | K062347 | 000 |