The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Ear Themometer, Models Td-1115 And Td-1118.
| Device ID | K100942 |
| 510k Number | K100942 |
| Device Name: | U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2010-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042012228 | K100942 | 000 |
| 80816042012231 | K100942 | 000 |