The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for 5 Sec Digital Clinical Thermometer, Models St8630x, St8640x, St8730x, St8740x, St8930x, St8940x, St8030x, St8040x..
| Device ID | K050303 |
| 510k Number | K050303 |
| Device Name: | 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. |
| 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 | 2005-02-08 |
| Decision Date | 2005-02-25 |
| Summary: | summary |