The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Blood Glucose Monitoring System ( Gm720, Rightest Professional Bgms Gm720.
| Device ID | K140210 |
| 510k Number | K140210 |
| Device Name: | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME CORPORATION 29222 RANCHO VIEJO ROAD SUITE 218 San Jun Capistrano, CA 92675 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee BIONIME CORPORATION 29222 RANCHO VIEJO ROAD SUITE 218 San Jun Capistrano, CA 92675 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-28 |
| Decision Date | 2014-08-22 |
| Summary: | summary |