Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K872534 |
Device Name |
4LYF OXYGEN CONCENTRATOR |
Applicant |
AIRSEP CORP. |
84 AERO DR. |
BUFFALO,
NY
14225
|
|
Applicant Contact |
PETER WEISENBORN |
Correspondent |
AIRSEP CORP. |
84 AERO DR. |
BUFFALO,
NY
14225
|
|
Correspondent Contact |
PETER WEISENBORN |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 06/26/1987 |
Decision Date | 10/13/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|