Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K230379 |
Device Name |
Portable (Ultrasonic) Nebulizer |
Applicant |
Dongguan SIMZO Electronic Technology Co.Ltd. |
No. 6 Zhangzhou Road, Daojiao Town |
Dongguan,
CN
523187
|
|
Applicant Contact |
Jack Jin |
Correspondent |
Shenzhen Reanny Medical Devices Management Consulting., Ltd |
Room 1407, Jingting Building, Dongzhou Community, |
Guangming Street, Guangming District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Reanny Wang |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/13/2023 |
Decision Date | 11/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|