The following data is part of a premarket notification filed by Shenzhen Jiacom Technology Co., Ltd with the FDA for Infrared Thermometer.
Device ID | K172874 |
510k Number | K172874 |
Device Name: | Infrared Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shenzhen Jiacom Technology Co., Ltd No. A6 Building, Silicon Valley Power, Qinghu Park, Longhua Street, Bao'an Dist Shenzhen, CN 518109 |
Contact | Luo Tianfeng |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-21 |
Decision Date | 2018-07-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06953205900863 | K172874 | 000 |
06953205900856 | K172874 | 000 |
06953205900849 | K172874 | 000 |
06953205900832 | K172874 | 000 |
06953205900825 | K172874 | 000 |
06953205900818 | K172874 | 000 |
00810477022845 | K172874 | 000 |
06953205900887 | K172874 | 000 |
06953205900870 | K172874 | 000 |