Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K942444 |
Device Name |
3002 AEROMAX |
Applicant |
MEDICAL INDUSTRIES AMERICA, INC. |
2879 R AVE. |
ADEL,
IA
50003 -8055
|
|
Applicant Contact |
MARK D HEBENSTREIT |
Correspondent |
MEDICAL INDUSTRIES AMERICA, INC. |
2879 R AVE. |
ADEL,
IA
50003 -8055
|
|
Correspondent Contact |
MARK D HEBENSTREIT |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/23/1994 |
Decision Date | 03/10/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|