Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K946095 |
Device Name |
DEVILBISS MODEL 5500 |
Applicant |
DEVILBISS HEALTH CARE, INC. |
1200 EAST MAIN ST. |
P.O.BOX 635 |
SOMERSET,
PA
15501 -0635
|
|
Applicant Contact |
BARRY IDDON |
Correspondent |
DEVILBISS HEALTH CARE, INC. |
1200 EAST MAIN ST. |
P.O.BOX 635 |
SOMERSET,
PA
15501 -0635
|
|
Correspondent Contact |
BARRY IDDON |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/14/1994 |
Decision Date | 08/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|