The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd with the FDA for Digital Thermometer.
| Device ID | K163518 |
| 510k Number | K163518 |
| Device Name: | Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | JOYTECH HEALTHCARE CO., LTD No. 365, Wuzhou Road Yuhang Economic Development Zone Hangzhou, CN 311100 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua JOYTECH HEALTHCARE CO., LTD No. 365, Wuzhou Road Yuhang Economic Development Zone 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 | 2016-12-15 |
| Decision Date | 2017-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810038632053 | K163518 | 000 |
| 00057565975106 | K163518 | 000 |
| 00057565975120 | K163518 | 000 |
| 00057565972846 | K163518 | 000 |
| 00057565972853 | K163518 | 000 |
| 00057565973447 | K163518 | 000 |
| 00057565973461 | K163518 | 000 |
| 00057565166252 | K163518 | 000 |
| 10875011006900 | K163518 | 000 |
| 10041220873729 | K163518 | 000 |
| 10041220873866 | K163518 | 000 |
| 00875011006910 | K163518 | 000 |