The following data is part of a premarket notification filed by Measure Technology Co. Ltd. with the FDA for Shaker Digital Thermometer.
Device ID | K112703 |
510k Number | K112703 |
Device Name: | SHAKER DIGITAL THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | MEASURE TECHNOLOGY CO. LTD. 7F, NO 86, SEC. 1, KWANG FU RD San Chung City, Taipei Hsiang, TW 241 |
Contact | Rack Yu |
Correspondent | Rack Yu MEASURE TECHNOLOGY CO. LTD. 7F, NO 86, SEC. 1, KWANG FU RD San Chung City, Taipei Hsiang, 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 | 2011-09-16 |
Decision Date | 2011-10-04 |
Summary: | summary |