The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, Ge Blood Glucose Monitoring System Max, Ge Blood Glucose Monitoring System Max Plus.
| Device ID | K173638 |
| 510k Number | K173638 |
| Device Name: | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist. Taichung, TW 40242 |
| Contact | Kay Wu |
| Correspondent | Feng-yu Lee Dynamic Biotech Inc. Dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 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 | 2017-11-24 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20883489001744 | K173638 | 000 |
| 20883489001720 | K173638 | 000 |
| 00883489001719 | K173638 | 000 |