The following data is part of a premarket notification filed by Putian Hanjiang Huafeng Plastic Co., Ltd. with the FDA for Electronic Thermometer (xhf2001, Xhf2002).
| Device ID | K211352 |
| 510k Number | K211352 |
| Device Name: | Electronic Thermometer (XHF2001, XHF2002) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Putian Hanjiang Huafeng Plastic Co., Ltd. 40M Road, Jiangkou Town, Hanjiang District Putian, CN 351111 |
| Contact | Yiqian Deng |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-09-09 |