Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K843691 |
Device Name |
PORTABLE OXYGEN UNIT |
Applicant |
B & F MEDICAL PRODUCTS, INC. |
P.O. BOX 3656 |
TOLEDO ,
OH
43608 -
|
|
Applicant Contact |
JAMES SPILLIS |
Correspondent |
B & F MEDICAL PRODUCTS, INC. |
P.O. BOX 3656 |
TOLEDO ,
OH
43608 -
|
|
Correspondent Contact |
JAMES SPILLIS |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 09/19/1984 |
Decision Date | 11/07/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|