The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Ir22 Ear Thermometer, Model Td-1262.
Device ID | K090294 |
510k Number | K090294 |
Device Name: | FORA IR22 EAR THERMOMETER, MODEL TD-1262 |
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 | 2009-02-05 |
Decision Date | 2009-02-26 |