Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K032170 |
Device Name |
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 |
Applicant |
MEDICAL INDUSTRIES AMERICA, INC. |
2636 289TH PLACE |
ADEL,
IA
50003 -8021
|
|
Applicant Contact |
ANNE B CARLSON |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED E DEVINE |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/16/2003 |
Decision Date | 05/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|