Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K852209 |
Device Name |
DEVO/MC29 OXYGEN CONCENTRATOR MC29D |
Applicant |
THE DEVILBISS CO. |
P.O. BOX 635 |
SOMERSET,
PA
15501
|
|
Applicant Contact |
JAMES C STANGE |
Correspondent |
THE DEVILBISS CO. |
P.O. BOX 635 |
SOMERSET,
PA
15501
|
|
Correspondent Contact |
JAMES C STANGE |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 05/21/1985 |
Decision Date | 06/24/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|