The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K201980 |
| 510k Number | K201980 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, CN 066004 |
| Contact | Xueyong Li |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District, 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 | 2020-07-16 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040105428 | K201980 | 000 |