The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Achtung Blood Glucose Monitoring System, Model Td-4207.
| Device ID | K061181 |
| 510k Number | K061181 |
| Device Name: | ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
| Contact | Pi-shiou Li |
| Correspondent | Pi-shiou Li TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, 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 | 2006-04-27 |
| Decision Date | 2006-07-06 |