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 |