The following data is part of a premarket notification filed by Joytech Healthcare Co.,ltd with the FDA for Infrared Forehead Thermometer, Infrared Ear/forehead Thermometer.
| Device ID | K181239 |
| 510k Number | K181239 |
| Device Name: | Infrared Forehead Thermometer, 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 | 2018-05-10 |
| Decision Date | 2018-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002249667 | K181239 | 000 |