The following data is part of a premarket notification filed by Comper Chuangxiang (beijing) Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer (model Ir-ft).
| Device ID | K191668 |
| 510k Number | K191668 |
| Device Name: | Infrared Forehead Thermometer (Model IR-FT) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Comper Chuangxiang (Beijing) Technology Co., Ltd. Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District, CN 100176 |
| Contact | Han Du |
| Correspondent | Han Du Comper Chuangxiang (Beijing) Technology Co., Ltd. Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District, CN 100176 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2019-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970528391109 | K191668 | 000 |
| 06974415521105 | K191668 | 000 |