The following data is part of a premarket notification filed by Bionime Coporation with the FDA for Rightest Blood Glucose Monitoring System Gm700, Rightest Blood Glucose Monitoring System Gm650, Ge200 Blood Glucose Monitoring System, And Ge300 Talking Blood Glucose Monitoring System.
| Device ID | K141292 |
| 510k Number | K141292 |
| Device Name: | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, And GE300 Talking Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME COPORATION 29222 RANCHO VIEJO ROAD, SUITE 218 San Jun Capistrano, CA 92675 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee BIONIME COPORATION 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 | 2014-05-19 |
| Decision Date | 2015-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883489002563 | K141292 | 000 |