Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K990506 |
Device Name |
MABIS NB-02 ULTRASONIC NEBULIZER |
Applicant |
MABIS HEALTHCARE, INC. |
28690 BALLARD DR. |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
STEVEN M BISULCA |
Correspondent |
MABIS HEALTHCARE, INC. |
28690 BALLARD DR. |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
STEVEN M BISULCA |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/17/1999 |
Decision Date | 03/11/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|