Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K132247 |
Device Name |
ULTRASONIC MESH NEBULIZER |
Applicant |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
11820 RED HIBISCUS DRIVE |
BONITA SPRINGS,
FL
34135
|
|
Applicant Contact |
GUENTER GINSBERG |
Correspondent |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
11820 RED HIBISCUS DRIVE |
BONITA SPRINGS,
FL
34135
|
|
Correspondent Contact |
GUENTER GINSBERG |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/19/2013 |
Decision Date | 01/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|