The following data is part of a premarket notification filed by Hetaida Technology Co., Ltd with the FDA for Non-contact Infrared Body Thermometer.
| Device ID | K171888 |
| 510k Number | K171888 |
| Device Name: | Non-contact Infrared Body Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Hetaida Technology Co., Ltd 4F, BaiShiDa High-Tech Park, XianDong Industrial Area, DaLingShan Dongguan, CN 523820 |
| Contact | Zhenguang Chen |
| Correspondent | Roman Huang Elliiot Medical Solutions 18586 Parkland Drive Shaker Heights, OH 44122 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2018-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970289030054 | K171888 | 000 |
| 16970289030047 | K171888 | 000 |
| 08719699630444 | K171888 | 000 |
| 08719699630437 | K171888 | 000 |
| 16970289030078 | K171888 | 000 |
| 00817915020142 | K171888 | 000 |
| 00634782899806 | K171888 | 000 |
| 00634782899783 | K171888 | 000 |
| 10328785006350 | K171888 | 000 |