Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K060811 |
Device Name |
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 |
Applicant |
OMRON HEALTHCARE, INC. |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
OMRON HEALTHCARE, INC. |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/24/2006 |
Decision Date | 05/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|