Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K091794 |
Device Name |
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 |
Applicant |
STEVE ISLAVA |
1599 SUPERIOR AVE, STE B5 |
COSTA MESA,
CA
92627
|
|
Applicant Contact |
JIM BARLEY |
Correspondent |
STEVE ISLAVA |
1599 SUPERIOR AVE, STE B5 |
COSTA MESA,
CA
92627
|
|
Correspondent Contact |
JIM BARLEY |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/17/2009 |
Decision Date | 01/28/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|