The following data is part of a premarket notification filed by Shenzhen Jiacom Technology Co ., Ltd with the FDA for Infrared Thermometer.
| Device ID | K172894 |
| 510k Number | K172894 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Jiacom Technology Co ., Ltd No. A6 Building, Silicon Valley Power Qinghu Park, Longhua Street, Bao’an Dist Shenzhen, CN 518109 |
| Contact | Luo Tianfeng |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2018-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06953205900801 | K172894 | 000 |
| 06953205900795 | K172894 | 000 |
| 06953205900788 | K172894 | 000 |