The following data is part of a premarket notification filed by Cotronic Technology Limited with the FDA for Digital Pacifier Thermometer (model No.: Tm-03).
| Device ID | K120671 |
| 510k Number | K120671 |
| Device Name: | DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | COTRONIC TECHNOLOGY LIMITED WEST OF ZHOU SHI RD XI XIANG ST, BAO AN ZONE Shen Zhen, Guang Dong, CN 518126 |
| Contact | Tani Mok |
| Correspondent | Tani Mok COTRONIC TECHNOLOGY LIMITED WEST OF ZHOU SHI RD XI XIANG ST, BAO AN ZONE Shen Zhen, Guang Dong, CN 518126 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-05 |
| Decision Date | 2013-05-17 |
| Summary: | summary |