The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Modification To Evencare Blood Glucose Monitoring System.
| Device ID | K031843 |
| 510k Number | K031843 |
| Device Name: | MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PL. Mundelein, IL 60060 -4486 |
| Contact | Andrea Haferkamp |
| Correspondent | Andrea Haferkamp MEDLINE INDUSTRIES, INC. ONE MEDLINE PL. Mundelein, IL 60060 -4486 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-07-03 |