The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080.
| Device ID | K090628 |
| 510k Number | K090628 |
| Device Name: | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE, LLC 777 OLD SAW MILL RIVER ROAD Tarrytown, NY 10591 |
| Contact | Susan Brocchi |
| Correspondent | Susan Brocchi BAYER HEALTHCARE, LLC 777 OLD SAW MILL RIVER ROAD Tarrytown, NY 10591 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-12-04 |
| Summary: | summary |