The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Blood Glucose Monitoring System Gm700s, Rightest Blood Glucose Monitoring System Gm700sb.
| Device ID | K190564 |
| 510k Number | K190564 |
| Device Name: | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist. Taichung, TW 40242 |
| Contact | Shane Chou |
| Correspondent | Feng-yu Lee Dynamic Biotech Inc. Dba IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212 San Juan 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 | 2019-03-05 |
| Decision Date | 2019-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883489002037 | K190564 | 000 |
| 00883489001993 | K190564 | 000 |