The following data is part of a premarket notification filed by Fudakang Industries Co., Ltd with the FDA for Infrared Thermometer (ft-f11-bt, Ft-f21-bt, Ft-31-bt, Ft-f41-bt).
| Device ID | K152640 |
| 510k Number | K152640 |
| Device Name: | Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FUDAKANG INDUSTRIES CO., LTD NO.8 YINGHE ROAD, YUANJIANGYUAN MANAGEMENT ZONE, CHANGPING TOWN Dongguan, CN 523560 |
| Contact | Bob Yu |
| Correspondent | Field Fu SHENZHEN JOYANTECH CONSULTING CO., LTD. 2032#, INTERNATIONAL MAYOR COMMUNICATION CENTER, SHIZHOU ZHONG ROAD 55#, NA Shenzhen, CN 518100 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859811007025 | K152640 | 000 |