The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for Thermometer Models St313c/f, St314c/f, St323c/f, St324c/f, St333c/f, St334c/f.
Device ID | K023956 |
510k Number | K023956 |
Device Name: | THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-27 |
Decision Date | 2004-06-17 |
Summary: | summary |