Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K033863 |
Device Name |
OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 |
Applicant |
OX-GEN INC. |
PO BOX 5867 |
BOISE,
ID
83702
|
|
Applicant Contact |
FRANK FOSELLA |
Correspondent |
OX-GEN INC. |
PO BOX 5867 |
BOISE,
ID
83702
|
|
Correspondent Contact |
FRANK FOSELLA |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 12/12/2003 |
Decision Date | 08/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|