Device Classification Name |
oximeter
|
510(k) Number |
K212300 |
Device Name |
Pulse Oximeter |
Applicant |
Shenzhen Mericonn Technology Co., Ltd. |
Room 20203, Building 6, Donglongxing Kejiyuan, Huaning Road |
Xinshishequ, Dalang Street |
Shenzhen,
CN
518109
|
|
Applicant Contact |
Jiang Chuanyuan |
Correspondent |
Chonconn Medical Device Consulting Co., Ltd. |
Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District |
Shenzhen,
CN
518067
|
|
Correspondent Contact |
Kevin Wang |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/22/2021 |
Decision Date | 02/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|