The following data is part of a premarket notification filed by Comper Chuangxiang (beijing) Technology Co., Ltd. with the FDA for Thermart (model Ir-eft).
| Device ID | K202481 |
| 510k Number | K202481 |
| Device Name: | ThermArt (Model IR-EFT) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Comper Chuangxiang (Beijing) Technology Co., Ltd. Building 1, Unit 4, Room 102, 103 1st Floor, No.1 Kangding Street, Beijing Economic Technological Development Area, Beijing, CN 100176 |
| Contact | Han Du |
| Correspondent | Han Du Comper Chuangxiang (Beijing) Technology Co., Ltd. Building 1, Unit 4, Room 102, 103 1st Floor, No.1 Kangding Street, Beijing Economic Technological Development Area Beijing, 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 | 2020-08-28 |
| Decision Date | 2021-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970528391130 | K202481 | 000 |
| 06974415521136 | K202481 | 000 |