The following data is part of a premarket notification filed by Bayer Healthcare Llc with the FDA for Didget World Reports.
| Device ID | K093930 |
| 510k Number | K093930 |
| Device Name: | DIDGET WORLD REPORTS |
| 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 |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-03-12 |
| Summary: | summary |