Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K062263 |
Device Name |
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 |
Applicant |
OMRON HEALTHCARE, INC. |
3460 POINTE CREEK COURT #102 |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
RANNDY KELLOGG |
Correspondent |
OMRON HEALTHCARE, INC. |
3460 POINTE CREEK COURT #102 |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
RANNDY KELLOGG |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/04/2006 |
Decision Date | 02/23/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|