Device Classification Name |
medevac use oxygen generator
|
510(k) Number |
K082829 |
Device Name |
AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) |
Applicant |
CARLETON LIFE SUPPORT SYSTEMS INC. |
2734 HICKORY GROVE RD. |
DAVENPORT,
IA
52804 -1203
|
|
Applicant Contact |
GARY BYRD |
Correspondent |
CARLETON LIFE SUPPORT SYSTEMS INC. |
2734 HICKORY GROVE RD. |
DAVENPORT,
IA
52804 -1203
|
|
Correspondent Contact |
GARY BYRD |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 09/25/2008 |
Decision Date | 12/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|