Device Classification Name |
Oximeter
|
510(k) Number |
K200069 |
Device Name |
Disposable SpO2 Sensor |
Applicant |
Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park |
No.87 of HengPing Road, Henggang |
Shenzhen,
CN
518000
|
|
Applicant Contact |
Yahui Zhou |
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 | 01/13/2020 |
Decision Date | 03/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|