The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for 10-second Digital Thermometer, Models St87, St89, St80, St88.
| Device ID | K041056 |
| 510k Number | K041056 |
| Device Name: | 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MESURE TECHNOLOGY CO.,LTD. 7F, 88, SEC. 1, KWANG FU ROAD SAN CHUNG CITY Taipei Hsien, TW R.o.c. |
| Contact | Roger Lu |
| Correspondent | Roger Lu MESURE TECHNOLOGY CO.,LTD. 7F, 88, SEC. 1, KWANG FU ROAD SAN CHUNG CITY Taipei Hsien, TW R.o.c. |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-23 |
| Decision Date | 2004-05-12 |
| Summary: | summary |