The following data is part of a premarket notification filed by Hetaida Technology Co., Ltd. with the FDA for Infrared Ear Thermometer.
Device ID | K180387 |
510k Number | K180387 |
Device Name: | Infrared Ear Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | HeTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Foshan City, CN 523820 |
Contact | Tom Chen |
Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, CN 510663 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-12 |
Decision Date | 2019-01-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
16970289030061 | K180387 | 000 |
40504280825158 | K180387 | 000 |