Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K200471 |
Device Name |
Infrared Thermometer Model Number RN-60A,RN-60B |
Applicant |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
No. 127 Fenghui Road, Wangchun Industrial Park, |
Haishu District |
Ningbo,
CN
315000
|
|
Applicant Contact |
Emma Hu |
Correspondent |
Shanghai Truthful Information Technology Co., Ltd. |
RM.608,No.738,Shangcheng Rd.,Pudong |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Boyle Wang |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 02/26/2020 |
Decision Date | 06/19/2020 |
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
|
|
|