The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Pocket Compass Diabetes Management Software.
| Device ID | K050760 |
| 510k Number | K050760 |
| Device Name: | ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE |
| Classification | Pump, Infusion, Insulin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-24 |
| Decision Date | 2005-09-13 |
| Summary: | summary |