The following data is part of a premarket notification filed by Hangzhou Hua'an Medical&health Instruments Co.,ltd with the FDA for Digital Thermometer(with Disposable Thermometer Cover).
| Device ID | K172861 |
| 510k Number | K172861 |
| Device Name: | Digital Thermometer(with Disposable Thermometer Cover) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Hangzhou Hua'an Medical&health Instruments Co.,Ltd Building 2, 1# Fuzhu Nan RD, Wuchang Town, Yuhang District Hangzhou, CN 310023 |
| Contact | Ahneo Yang |
| Correspondent | Ahneo Yang Hangzhou Hua'an Medical&health Instruments Co.,Ltd Building 2, 1# Fuzhu Nan RD, Wuchang Town, Yuhang District Hangzhou, CN 310023 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2017-12-19 |