Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K202389 |
Device Name |
Oxygen Concentrator |
Applicant |
Foshan MIC Medical Technology Co., LTD |
U501-1,503, 5F, No.7 Building, Zone A Hantian |
Industrial Park 17th Shenhai R |
Foshan,
CN
528200
|
|
Applicant Contact |
Wu Huahong |
Correspondent |
Share Info (Guangzhou) Medical Consultant Ltd. |
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, |
Huangpu District |
Guangzhou,
CN
510000
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 08/21/2020 |
Decision Date | 04/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|