Bionime Corporation · Class II · Cleared Jul 6, 2017
| K-number | K170143 |
| Device name | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, |
| Applicant | Bionime Corporation |
| Product code | NBW |
| Device class | Class II |
| Decision date | Jul 6, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov