Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K171455 |
Device Name |
AT-6XX Series Infrared Thermometer |
Applicant |
Xiamen Acurio Instruments Co., Ltd |
3rd-4th Floors, BI Park, No.2028 |
Wengjiao West Road, Haicang District |
Xiamen,
CN
361026
|
|
Applicant Contact |
Angel Liu |
Correspondent |
Xiamen Acurio Instruments Co., Ltd |
3rd-4th Floors, BI Park, No.2028 |
Wengjiao West Road, Haicang District |
Xiamen,
CN
361026
|
|
Correspondent Contact |
Angel Liu |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 05/17/2017 |
Decision Date | 02/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|