Device Classification Name |
Regulator, Pressure, Gas Cylinder
|
510(k) Number |
K843585 |
Device Name |
BEMCO PORTABLE OXYGEN INHALATOR |
Applicant |
BEMCO, INC. |
25 SASS ROAD, R.R.#4 |
CHATHAM ONT. N7M 5J4,
CA
|
|
Applicant Contact |
AUSTIN L BEARD |
Correspondent |
BEMCO, INC. |
25 SASS ROAD, R.R.#4 |
CHATHAM ONT. N7M 5J4,
CA
|
|
Correspondent Contact |
AUSTIN L BEARD |
Regulation Number | 868.2700
|
Classification Product Code |
|
Date Received | 09/11/1984 |
Decision Date | 10/12/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|