The following data is part of a premarket notification filed by Hetaida Technology Co., Ltd with the FDA for Non-contact Infrared Body Thermometer.
Device ID | K171888 |
510k Number | K171888 |
Device Name: | Non-contact Infrared Body Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Hetaida Technology Co., Ltd 4F, BaiShiDa High-Tech Park, XianDong Industrial Area, DaLingShan Dongguan, CN 523820 |
Contact | Zhenguang Chen |
Correspondent | Roman Huang Elliiot Medical Solutions 18586 Parkland Drive Shaker Heights, OH 44122 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-26 |
Decision Date | 2018-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
16970289030054 | K171888 | 000 |
16970289030047 | K171888 | 000 |
08719699630444 | K171888 | 000 |
08719699630437 | K171888 | 000 |
16970289030078 | K171888 | 000 |
00817915020142 | K171888 | 000 |
00634782899806 | K171888 | 000 |
00634782899783 | K171888 | 000 |