Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K192633 |
Device Name |
GUS831 Compressor Nebulizer |
Applicant |
Globalcare Medical Technology Co., Ltd. |
7th Building, 39 Middle Industrial Main Road, European |
Industrial Zone |
Xiaolan Town, Zhongshan City,
CN
528415
|
|
Applicant Contact |
Janice Deng |
Correspondent |
Chonconn Medical Device Consulting Co., Ltd. |
No. A415, Block A, Nanshan Medical device industrial park, |
Nanshan District |
Shenzhen,
CN
518067
|
|
Correspondent Contact |
Kevin Wang |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/23/2019 |
Decision Date | 05/01/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|