Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K192971 |
Device Name |
Nebulizer Kit |
Applicant |
Excellentcare Medical (Huizhou) Ltd. |
Shatou Industrial Zone. Yuanzhou Town. |
Huizhou,
CN
516123
|
|
Applicant Contact |
Chunyu Zhao |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd. |
NO. 55 Shizhou middle road, Nanshan District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Elly Xu |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/23/2019 |
Decision Date | 07/08/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|