The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-1240 Thermometer.
| Device ID | K113159 |
| 510k Number | K113159 |
| Device Name: | U-RIGHT TD-1240 THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Contact | Linda Ko |
| Correspondent | Linda Ko TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, 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 | 2011-10-26 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042013225 | K113159 | 000 |