The following data is part of a premarket notification filed by Mesure Technology Co.,ltd. with the FDA for Wireless Temperature Monitor / Models St323c And St323f..
Device ID | K063542 |
510k Number | K063542 |
Device Name: | WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. |
Classification | Thermometer, Electronic, Clinical |
Applicant | MESURE TECHNOLOGY CO.,LTD. 7F,86, SEC.1,KWANG FU ROAD Sanchung City, Taipei Hsien, TW 241 |
Contact | John Chen |
Correspondent | John Chen MESURE TECHNOLOGY CO.,LTD. 7F,86, SEC.1,KWANG FU ROAD Sanchung City, Taipei Hsien, 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 | 2006-11-24 |
Decision Date | 2007-04-10 |
Summary: | summary |