The following data is part of a premarket notification filed by Shenzhen Zhengkang Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer, Model Jzk-601, Jzk-602, Jzk-603.
| Device ID | K203707 |
| 510k Number | K203707 |
| Device Name: | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ShenZhen ZhengKang Technology Co., Ltd. 2&3/F, Building A, No.3 FuXing Yi Lane, HeHua Community, PingHu Street Shenzhen, CN 518100 |
| Contact | Huayong Yang |
| Correspondent | Iris Wang Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06922119300175 | K203707 | 000 |
| 06922119300168 | K203707 | 000 |
| 06922119300113 | K203707 | 000 |