The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Non-contact Forehead Thermometer.
| Device ID | K161735 |
| 510k Number | K161735 |
| Device Name: | Non-contact Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Contact | Siping Yuan |
| Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816479015601 | K161735 | 000 |
| 06926408700165 | K161735 | 000 |
| 16926408700209 | K161735 | 000 |
| 06926408700455 | K161735 | 000 |
| 20311917221384 | K161735 | 000 |
| 10891040701173 | K161735 | 000 |