The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Infrared Thermometer.
| Device ID | K180314 |
| 510k Number | K180314 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Xuzhou Yongkang Electronic Science Technology Co., Ltd 4F Building C8,40 Jingshan Road Econonic And Technolgical Development Zone Xuzhou, CN 102628 |
| Contact | Xuecheng Zhao |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-05 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856324008181 | K180314 | 000 |