The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Comfortscan Ear Thermometer, Models Td-1261a; Td-1261b.
| Device ID | K081445 |
| 510k Number | K081445 |
| Device Name: | FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-08-11 |
| Summary: | summary |