The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Iglucose Blood Glucose Monitoring System.
| Device ID | K161790 |
| 510k Number | K161790 |
| Device Name: | IGlucose Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME CORPORATION NO. 100, Sec. 2, Daqing St., South Dist. Taichung City, TW 40242 |
| Contact | Tino Lee |
| Correspondent | Nina Peled MEDICAL DEVICE REGULATORY CONSULTANTS 627 16TH AVE. Menlo Park, CA 94025 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-29 |
| Decision Date | 2017-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883489001542 | K161790 | 000 |
| 00883489001504 | K161790 | 000 |
| 00883489002525 | K161790 | 000 |