The following data is part of a premarket notification filed by Visgeneer, Inc. with the FDA for Ebcarryon Blood Glucose Monitoring System.
| Device ID | K091765 |
| 510k Number | K091765 |
| Device Name: | EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | VISGENEER, INC. 3F-2, NO. 83, SEC. 2 GONGDAO 5TH ROAD Hsinchu City, TW 30070 |
| Contact | Evonne Chen |
| Correspondent | Evonne Chen VISGENEER, INC. 3F-2, NO. 83, SEC. 2 GONGDAO 5TH ROAD Hsinchu City, TW 30070 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2010-01-19 |
| Summary: | summary |