The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Ascensia Breeze Blood Glucose Meter.
| Device ID | K024062 |
| 510k Number | K024062 |
| Device Name: | ASCENSIA BREEZE BLOOD GLUCOSE METER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -0070 |
| Contact | George M Tancos |
| Correspondent | George M Tancos BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -0070 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-09 |
| Decision Date | 2003-03-03 |
| Summary: | summary |