The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Td-1107 Ear/skin/surface Ir Thermometer, Clever Td-1110 Ear/skin/surface Ir Thermometer.
Device ID | K050463 |
510k Number | K050463 |
Device Name: | CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Contact | Shu-mei Wu |
Correspondent | Shu-mei Wu TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-23 |
Decision Date | 2005-07-27 |
Summary: | summary |