K050760 is an FDA 510(k) clearance for the ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 13, 2005, 173 days after receiving the submission on March 24, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K050760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2005 |
| Decision Date | September 13, 2005 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |