The following data is part of a premarket notification filed by Arkray Factory Usa, Inc. with the FDA for Arkray Diabetes Data Management Software (smbg Viewer).
| Device ID | K093819 |
| 510k Number | K093819 |
| Device Name: | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Tom Speikers |
| Correspondent | Tom Speikers ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-06-09 |
| Summary: | summary |