K113007 is an FDA 510(k) clearance for the BIONIME DIABETES MANAGEMENT SYSTEM VI.0. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP).
Submitted by Bionime Corporation (Mission Viejo, US). The FDA issued a Cleared decision on February 27, 2012, 143 days after receiving the submission on October 7, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K113007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2011 |
| Decision Date | February 27, 2012 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JQP — Calculator/data Processing Module, For Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2100 |