The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Link Wireless Blood Glucose Monitor.
| Device ID | K122370 |
| 510k Number | K122370 |
| Device Name: | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301939740011 | K122370 | 000 |
| 40301936207012 | K122370 | 000 |