The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Models Fora V30 And Td-4242 Blood Glucose Monitoring Systems.
| Device ID | K093635 |
| 510k Number | K093635 |
| Device Name: | MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Debra Liang |
| Correspondent | Debra Liang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011702 | K093635 | 000 |
| 00816042011672 | K093635 | 000 |
| 00816042011139 | K093635 | 000 |
| 00816042010675 | K093635 | 000 |