The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Td-1112 Ear/skin/surface Ir Thermometer.
| Device ID | K061800 |
| 510k Number | K061800 |
| Device Name: | CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| 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 | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-07-07 |