The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-4227 No Coding Blood Glucose Monitoring System, Model Td-4222.
| Device ID | K090188 |
| 510k Number | K090188 |
| Device Name: | U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-26 |
| Decision Date | 2009-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042012723 | K090188 | 000 |
| 00739810207742 | K090188 | 000 |
| 00739810207735 | K090188 | 000 |
| 00739810205885 | K090188 | 000 |
| 00850009854018 | K090188 | 000 |