The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Taidoc Td-11 Series And Clever Td-1112 Ear/skin/ Surface Ir Thermometers & Fora Ir16/17 Ear Thermometer.
| Device ID | K083299 |
| 510k Number | K083299 |
| Device Name: | TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Jeff Wang |
| Correspondent | Jeff Wang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2008-12-10 |