Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K210371 |
Device Name |
Portable Oxygen Concentrator, model: P2-E6 |
Applicant |
Qingdao Kingon Medical Science and Technology Co., Ltd. |
Room 301-302, No.15 HanchengRoad |
Qingdao Free Trade Zone,
CN
266555
|
|
Applicant Contact |
Zhang Benrong |
Correspondent |
Qimmiq Medical Consulting Service Co., Ltd |
RM.1711, Building K, NO.101 Science Ave International |
Creative Valley |
Guangzhou,
CN
510663
|
|
Correspondent Contact |
You Yijie |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 02/08/2021 |
Decision Date | 06/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|