The following data is part of a premarket notification filed by Visgeneer, Inc. with the FDA for Ebchek Blood Glucose Monitoring System.
| Device ID | K122181 |
| 510k Number | K122181 |
| Device Name: | EBCHEK BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | VISGENEER, INC. NO. 188, SEC. 3 GONGDAO 5TH ROAD Hsinchu City, TW 30069 |
| Contact | Jack Yang |
| Correspondent | Jack Yang VISGENEER, INC. NO. 188, SEC. 3 GONGDAO 5TH ROAD Hsinchu City, TW 30069 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2013-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14712558769416 | K122181 | 000 |
| 14712558769409 | K122181 | 000 |
| 04712558769419 | K122181 | 000 |
| 04712558769402 | K122181 | 000 |