Device Classification Name |
mixer, breathing gases, anesthesia inhalation
|
510(k) Number |
K092484 |
Device Name |
HELIOX LOW FLOW SENTRY BLENDER |
Applicant |
CARDINAL HEALTH 207, INC. |
22745 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
MONTHER ABUSHABAN |
Correspondent |
CARDINAL HEALTH 207, INC. |
22745 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
MONTHER ABUSHABAN |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 08/13/2009 |
Decision Date | 04/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|