Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K212395 |
Device Name |
Nebulizer |
Applicant |
Shenzhen Homed Medical Device Co., Ltd. |
3rd Floor, Block 1, Longquan Industrial Zone, |
Huarong Road, Dalang Street |
Shenzhen,
CN
518109
|
|
Applicant Contact |
Shi Shengming |
Correspondent |
Shenzhen Homed Medical Device Co., Ltd. |
3rd Floor, Block 1, Longquan Industrial Zone, |
Huarong Road, Dalang Street |
Shenzhen,
CN
518109
|
|
Correspondent Contact |
Shi Shengming |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/02/2021 |
Decision Date | 03/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|