The following data is part of a premarket notification filed by Kangzhan Communication Electronics Co., Ltd. with the FDA for Infrared Thermometer (model K9).
| Device ID | K203497 |
| 510k Number | K203497 |
| Device Name: | Infrared Thermometer (Model K9) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Kangzhan Communication Electronics Co., Ltd. No. 1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District Shenzhen, CN 518055 |
| Contact | Su Baotong |
| Correspondent | Su Baotong Kangzhan Communication Electronics Co., Ltd. No. 1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District Shenzhen, CN 518055 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-10-08 |