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 |