The following data is part of a premarket notification filed by Huaian Zhongxin Packing Material Co., Ltd. with the FDA for Disposable Ear Thermometer Probe Cover.
| Device ID | K203431 |
| 510k Number | K203431 |
| Device Name: | Disposable Ear Thermometer Probe Cover |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Huaian Zhongxin Packing Material Co., Ltd. No. 128-5, West Meigao Road, Qingpu Industrial Park Huaian, CN 223022 |
| Contact | Feng Zuo |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong 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 | 2020-11-23 |
| Decision Date | 2021-07-28 |