The following data is part of a premarket notification filed by Hangzhou Hua'an Medical&health Instruments Co.,ltd with the FDA for Infra-red Ear Thermometer Model: Et-100a, Et-100b, Et-100d, Et-100e, Et-100g, Et-100i, Et-100j.
| Device ID | K172870 |
| 510k Number | K172870 |
| Device Name: | Infra-red Ear Thermometer Model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J |
| 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 | 2018-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20891040701002 | K172870 | 000 |
| 06931562700623 | K172870 | 000 |