The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for Digital Clinical Thermometer, Models St-8a3c And St-8a3f.
| Device ID | K042013 |
| 510k Number | K042013 |
| Device Name: | DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F |
| 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 | John Chen |
| Correspondent | John Chen 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 | 2004-07-27 |
| Decision Date | 2004-09-08 |
| Summary: | summary |