The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for Ear Thermometer Models St61, St62, St63, St64, And St65.
| Device ID | K042627 |
| 510k Number | K042627 |
| Device Name: | EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MESURE TECHNOLOGY CO.,LTD. 7F,86,SEC.1, KWANG FU ROAD San Chung City, TW 241 |
| Contact | John Chen |
| Correspondent | John Chen MESURE TECHNOLOGY CO.,LTD. 7F,86,SEC.1, KWANG FU ROAD San Chung City, 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 | 2004-09-27 |
| Decision Date | 2004-10-18 |
| Summary: | summary |