The following data is part of a premarket notification filed by Shandong Bittel Intelligent Technology Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K202368 |
| 510k Number | K202368 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shandong Bittel Intelligent Technology Co., Ltd. No.1 Rizhao North Road Rizhao, CN 276800 |
| Contact | Cui Shi |
| 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 | 2020-08-19 |
| Decision Date | 2021-02-12 |