Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K131506 |
Device Name |
AIRWAY SUPPORT SYSTEM / AIRPORT |
Applicant |
ABEON MEDICAL CORPORATION |
8000 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Applicant Contact |
ALLISON SLAGA |
Correspondent |
ABEON MEDICAL CORPORATION |
8000 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Correspondent Contact |
ALLISON SLAGA |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 05/24/2013 |
Decision Date | 03/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|