Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K210126 |
Device Name |
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% |
Applicant |
The Ritedose Corporation |
1 Technology Circle |
Columbia,
SC
29203
|
|
Applicant Contact |
Linda Valentine |
Correspondent |
The Ritedose Corporation |
1 Technology Circle |
Columbia,
SC
29203
|
|
Correspondent Contact |
Linda Valentine |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 01/19/2021 |
Decision Date | 12/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|