The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Ir20b Ear Thermometer, Model Td-1261f, Fora Ir21b Ear Thermometer, Model Td-1261e.
| Device ID | K090395 |
| 510k Number | K090395 |
| Device Name: | FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, 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 | 2009-02-17 |
| Decision Date | 2009-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042013430 | K090395 | 000 |
| 00816042012181 | K090395 | 000 |
| 80816042011814 | K090395 | 000 |
| 00816042014710 | K090395 | 000 |
| 00816042013928 | K090395 | 000 |
| 00816042014024 | K090395 | 000 |
| 00816042011276 | K090395 | 000 |
| 00816042011726 | K090395 | 000 |
| 00816042012198 | K090395 | 000 |
| 80816042011098 | K090395 | 000 |