Device Classification Name |
Oximeter
|
510(k) Number |
K191279 |
Device Name |
Disposable SpO2 Sensor |
Applicant |
Shenzhen Caremed Medical Technology Co., Ltd. |
East Side, 3/F, C Building, Kelunte Low-Carbon Industries |
Gaofeng Community |
Dalang Office, Longhua District, Shenzhe,
CN
518109
|
|
Applicant Contact |
Alan Xie |
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 | 05/13/2019 |
Decision Date | 12/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|