Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K974379 |
Device Name |
ULTRANEB |
Applicant |
BREMED ITALIA, S.R.L. |
1337 ROCKWOOD FOREST DR. |
ARNOLD,
MO
63010
|
|
Applicant Contact |
MARK HEBENSTREIT |
Correspondent |
BREMED ITALIA, S.R.L. |
1337 ROCKWOOD FOREST DR. |
ARNOLD,
MO
63010
|
|
Correspondent Contact |
MARK HEBENSTREIT |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 11/20/1997 |
Decision Date | 02/18/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|