The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Bionime Diabetes Management System Vi.0.
| Device ID | K113007 |
| 510k Number | K113007 |
| Device Name: | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | BIONIME CORPORATION 27001 LA PAZ RD. SUITE 266B Mission Viejo, CA 92691 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee BIONIME CORPORATION 27001 LA PAZ RD. SUITE 266B Mission Viejo, CA 92691 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-07 |
| Decision Date | 2012-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20883489001461 | K113007 | 000 |
| 20883489001485 | K113007 | 000 |