The following data is part of a premarket notification filed by Bionime Coporation with the FDA for Rightest Diabetes Management Software And Adapter (existing Cleared K113007),rightest New Adapters-3,ge Diabetes Managem.
| Device ID | K133522 |
| 510k Number | K133522 |
| Device Name: | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME COPORATION 2700 LA PAZ ROAD SUITE 266B Mission Viejo, CA 92691 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee BIONIME COPORATION 2700 LA PAZ ROAD SUITE 266B Mission Viejo, CA 92691 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JQP |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-04-17 |
| Summary: | summary |