The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for Ear Thermometer, Models St66 And St67.
| Device ID | K080981 |
| 510k Number | K080981 |
| Device Name: | EAR THERMOMETER, MODELS ST66 AND ST67 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MESURE TECHNOLOGY CO.,LTD. 7F,86, SEC.1,KWANG FU ROAD Sanchung City, Taipei Hsien, TW 241 |
| Contact | John Chen |
| Correspondent | John Chen MESURE TECHNOLOGY CO.,LTD. 7F,86, SEC.1,KWANG FU ROAD Sanchung City, Taipei Hsien, 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 | 2008-04-07 |
| Decision Date | 2008-05-02 |
| Summary: | summary |