Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K991569 |
Device Name |
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 |
Applicant |
02 MARKETING GROUP, INC. |
11285 ELKINS RD. |
SUITE H5 |
ROSWELL,
GA
30076
|
|
Applicant Contact |
LESTER FORD |
Correspondent |
02 MARKETING GROUP, INC. |
11285 ELKINS RD. |
SUITE H5 |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
LESTER FORD |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 05/05/1999 |
Decision Date | 08/03/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|