Device Classification Name |
Oximeter
|
510(k) Number |
K192608 |
Device Name |
Disposable SpO2 Sensor |
Applicant |
Shenzhen SINO-K Medical Technology Co., Ltd. |
Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang |
Street, |
Baoan District, Shenzhen,
CN
518000
|
|
Applicant Contact |
Lao Chengxin |
Correspondent |
Chonconn Medical Device Consulting Co., Ltd. |
No. A415, Block A, NanShan Medical devices Industrial Park, |
Nanshan District |
Shenzhen,
CN
518067
|
|
Correspondent Contact |
Kevin Wang |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/20/2019 |
Decision Date | 01/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|