The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Link Wireless Blood Glucose Meter.
| Device ID | K110894 |
| 510k Number | K110894 |
| Device Name: | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Contact | Roger Sonnenburg |
| Correspondent | Roger Sonnenburg BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2012-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301939632019 | K110894 | 000 |
| 40301939624014 | K110894 | 000 |
| 40301936203014 | K110894 | 000 |
| 40301936201010 | K110894 | 000 |