The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd. with the FDA for Infrared Ear/forehead Thermometer.
Device ID | K190873 |
510k Number | K190873 |
Device Name: | Infrared Ear/Forehead Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
Contact | Ren Yunhua |
Correspondent | Ren Yunhua Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-03 |
Decision Date | 2019-07-26 |
Summary: | summary |