The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Td-1107 Ear/skin/surface Ir Thermometer, Clever Td-1110 Ear/skin/surface Ir Thermometer.
| Device ID | K050463 |
| 510k Number | K050463 |
| Device Name: | CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 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 | Shu-mei Wu |
| Correspondent | Shu-mei Wu 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-23 |
| Decision Date | 2005-07-27 |
| Summary: | summary |