The following data is part of a premarket notification filed by Kangfu Medical Equipment Factory with the FDA for Infrared Thermometer, Models Kft-22m, Kft-22, Kft-23, Kft-24, Kft-25, Kft-26, Kft-27, Kft-28.
| Device ID | K201600 |
| 510k Number | K201600 |
| Device Name: | Infrared Thermometer, Models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Kangfu Medical Equipment Factory No.380 Ningkang East Road, Lecheng Town, Yueqing Wenzhou, CN 325699 |
| Contact | Jixiang Zhang |
| Correspondent | Jixiang Zhang Kangfu Medical Equipment Factory No.380 Ningkang East Road, Lecheng Town, Yueqing Wenzhou, CN 325699 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2021-12-10 |