The following data is part of a premarket notification filed by Suzhou Melodicare Medical Technology Co.,ltd. with the FDA for Infrared Thermometer, Breeze Model.
| Device ID | K191283 |
| 510k Number | K191283 |
| Device Name: | Infrared Thermometer, Breeze Model |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Suzhou Melodicare Medical Technology Co.,Ltd. Building Room 301, No 32 Hongxi Road, Suzhou High-Tech Zone Suzhou, CN 215163 |
| Contact | Xiaoqian Zou |
| Correspondent | Xiaoqian Zou Suzhou Melodicare Medical Technology Co.,Ltd. Building Room 301, No 32 Hongxi Road, Suzhou High-Tech Zone Suzhou, CN 215163 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-10-18 |