The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd. with the FDA for Infrared Ear/forehead Thermometer.
| Device ID | K190873 |
| 510k Number | K190873 |
| Device Name: | Infrared Ear/Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-03 |
| Decision Date | 2019-07-26 |
| Summary: | summary |