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 Forehead Thermometer.
| Device ID | K160999 |
| 510k Number | K160999 |
| Device Name: | Infra-red Forehead Thermometer |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06931562700883 | K160999 | 000 |
| 05060505400014 | K160999 | 000 |
| 06931562701477 | K160999 | 000 |
| 06931562701637 | K160999 | 000 |
| 06931562701323 | K160999 | 000 |