Device Classification Name |
Oximeter
|
510(k) Number |
K203812 |
Device Name |
Oxyfit Pulse Oximeter |
Applicant |
Shenzhen Viatom Technology Co., Ltd. |
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road |
Block 67, Xin’an Street, Baoan District, 5 |
Shenzhen,
CN
518101
|
|
Applicant Contact |
Zhou Saixin |
Correspondent |
Shenzhen Viatom Technology Co., Ltd. |
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road |
Block 67, Xin’an Street, Baoan District, 5 |
Shenzhen,
CN
518101
|
|
Correspondent Contact |
Weifeng Tao |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/28/2020 |
Decision Date | 11/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|