The following data is part of a premarket notification filed by Xiamen Acurio Instruments Co., Ltd with the FDA for At-6xx Series Infrared Thermometer.
| Device ID | K171455 |
| 510k Number | K171455 |
| Device Name: | AT-6XX Series Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen, CN 361026 |
| Contact | Angel Liu |
| Correspondent | Angel Liu Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen, CN 361026 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-17 |
| Decision Date | 2018-02-09 |
| Summary: | summary |