The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora G31a/td-4256a Blood Glucose Monitoring System And Fora G31b/td-4256b Blood Glucose Monitoring System.
| Device ID | K094005 |
| 510k Number | K094005 |
| Device Name: | FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-28 |
| Decision Date | 2010-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011665 | K094005 | 000 |