The following data is part of a premarket notification filed by Shenzhen Urion Technology Co., Ltd with the FDA for Infrared Thermometer.
| Device ID | K200802 |
| 510k Number | K200802 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Urion Technology Co., Ltd 4-6F Of Building D, Jiale Science& Technology Industrial Zone, Heshuikou Comm Shenzhen, CN 518106 |
| Contact | Autumn Liu |
| Correspondent | Changming Zhu Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, CN 518105 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06953825904043 | K200802 | 000 |
| 06953825904159 | K200802 | 000 |
| 06953825904135 | K200802 | 000 |
| 06953825904128 | K200802 | 000 |
| 06953825904111 | K200802 | 000 |
| 06953825904098 | K200802 | 000 |
| 16953825906051 | K200802 | 000 |
| 16953825906181 | K200802 | 000 |
| 16953825906426 | K200802 | 000 |
| 16953825907409 | K200802 | 000 |
| 16953825903494 | K200802 | 000 |
| 16953825908185 | K200802 | 000 |
| 16953825908543 | K200802 | 000 |
| 06953825905576 | K200802 | 000 |
| 06953825905354 | K200802 | 000 |
| 06953825905279 | K200802 | 000 |
| 06953825904036 | K200802 | 000 |
| 06953825904029 | K200802 | 000 |
| 06953825904012 | K200802 | 000 |
| 06953825903992 | K200802 | 000 |
| 06953825903985 | K200802 | 000 |
| 06953825904333 | K200802 | 000 |
| 06953825906030 | K200802 | 000 |
| 06953825906023 | K200802 | 000 |
| 06953825906016 | K200802 | 000 |
| 06953825907020 | K200802 | 000 |
| 06953825907563 | K200802 | 000 |
| 06953825905194 | K200802 | 000 |
| 16953825908819 | K200802 | 000 |