Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K952268 |
Device Name |
MODEL DELTA, OM OXYGEN CONCENTRATOR |
Applicant |
CAIRE, INC. |
10488 WEST CENTENNIAL RD. |
LITTLETON,
CO
80127
|
|
Applicant Contact |
LINDA CHJAPMAN |
Correspondent |
CAIRE, INC. |
10488 WEST CENTENNIAL RD. |
LITTLETON,
CO
80127
|
|
Correspondent Contact |
LINDA CHJAPMAN |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 05/15/1995 |
Decision Date | 08/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|