Device Classification Name |
Oximeter
|
510(k) Number |
K183277 |
Device Name |
SpO2 Sensor |
Applicant |
Shenzhen Upnmed Equipment Co., Ltd. |
4th Floor, Building #1 East, Huijuang Industrial Area |
Xitian Community, Gongming Town, Guangming District |
Shenzhen,
CN
518107
|
|
Applicant Contact |
Fu Jian |
Correspondent |
Shenzhen Upnmed Equipment Co., Ltd. |
4th Floor, Building #1 East, Huihuang Industrial Area |
Xitian Community, Gongming Town, Guangming District |
Shenzhen,
CN
518107
|
|
Correspondent Contact |
Fu Jian |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 11/23/2018 |
Decision Date | 05/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|