Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K121167 |
Device Name |
CAIRE COMPANION 5 OXYGEN CONCENTRATOR |
Applicant |
CAIRE INC. |
2200 AIRPORT INDUSTRIAL DRIVE |
SUITE 500 |
BALL GROUND,
GA
30107
|
|
Applicant Contact |
BEN KADRLIK |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
PAULA WILKERSON |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 04/17/2012 |
Decision Date | 05/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|