The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Comfort 4 In 1 Ear Thermometer, Model Td-1116.
| Device ID | K080593 |
| 510k Number | K080593 |
| Device Name: | FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen 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 | 2008-03-03 |
| Decision Date | 2008-04-02 |