The following data is part of a premarket notification filed by Shenzhen Aeon Technology Co.,ltd. with the FDA for Infrared Thermometer.
Device ID | K171578 |
510k Number | K171578 |
Device Name: | Infrared Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shenzhen Aeon Technology Co.,Ltd. East 5/F, Block 15 Industrial Zone Of Majialong Nanshan District Shenzhen, CN 51800 |
Contact | Applicant Wendy |
Correspondent | Mei Tan Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square, No. 18, Taizi Road, Nanshan District Shenzhen, CN 51800 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-31 |
Decision Date | 2017-11-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10818323023548 | K171578 | 000 |
06947832500282 | K171578 | 000 |
06947832500138 | K171578 | 000 |
36947832500092 | K171578 | 000 |
00810477022197 | K171578 | 000 |
00810477021558 | K171578 | 000 |
00810477022838 | K171578 | 000 |
00810477023637 | K171578 | 000 |