The following data is part of a premarket notification filed by Intrinity Global Limited with the FDA for Non Contact Infrared Forehead Thermometer.
| Device ID | K170662 |
| 510k Number | K170662 |
| Device Name: | Non Contact Infrared Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Intrinity Global Limited Room 1707, 17/F, Westley Square 48Hoi Yuen Road, Kwun Tong Hong Kong, CN 999077 |
| Contact | Alex Kwok |
| Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road, Nanshan District Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-03 |
| Decision Date | 2017-11-22 |
| Summary: | summary |