Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K172234 |
Device Name |
Oxygen Concentrator |
Applicant |
SysMed (China) Co., Ltd |
11-2-3 No. 17 Wensu Str., Hunnan New Dis. |
Shenyang,
CN
110171
|
|
Applicant Contact |
Jian Yue |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 07/25/2017 |
Decision Date | 06/01/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|