Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K182906 |
Device Name |
Portable Mesh Nebulizer |
Applicant |
FeelLife Health Inc. |
Room 1903, Building A, No.9 Furong Road, Tantou Bao'an |
District |
Shenzhen,
CN
518104
|
|
Applicant Contact |
Owen Zhang |
Correspondent |
Medwheat (Shanghai) Medical Technology Co. Ltd. |
Yangpu District Liaoyuan East Road Shuangyang First Suite |
No. 33 Room 303 |
Shanghai,
CN
200082
|
|
Correspondent Contact |
Jonathan Hu |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/17/2018 |
Decision Date | 09/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|