Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K012037 |
Device Name |
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 |
Applicant |
AIRSEP CORP. |
290 CREEKSIDE DR. |
BUFFALO,
NY
14228
|
|
Applicant Contact |
CHARLOTTE H HAMILTON |
Correspondent |
AIRSEP CORP. |
290 CREEKSIDE DR. |
BUFFALO,
NY
14228
|
|
Correspondent Contact |
CHARLOTTE H HAMILTON |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 06/29/2001 |
Decision Date | 01/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|