Device Classification Name |
mixer, breathing gases, anesthesia inhalation
|
510(k) Number |
K101286 |
Device Name |
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 |
Applicant |
LINDE HEALTHCARE AB |
AGAVAGEN 54 |
LIDINGO,
SE
SE 18181
|
|
Applicant Contact |
ANDERS PALM |
Correspondent |
LINDE HEALTHCARE AB |
AGAVAGEN 54 |
LIDINGO,
SE
SE 18181
|
|
Correspondent Contact |
ANDERS PALM |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 05/07/2010 |
Decision Date | 10/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|