K080227 is an FDA 510(k) clearance for the ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 15, 2008, 106 days after receiving the submission on January 30, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K080227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2008 |
| Decision Date | May 15, 2008 |
| Days to Decision | 106 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ — Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |