Device Classification Name |
conserver, oxygen
|
510(k) Number |
K962766 |
Device Name |
AIRSEP IMPULSE |
Applicant |
AIRSEP CORP. |
290 CREEKSIDE DR. |
BUFFALO,
NY
14228
|
|
Applicant Contact |
MARK MIZERKIEWICZ |
Correspondent |
AIRSEP CORP. |
290 CREEKSIDE DR. |
BUFFALO,
NY
14228
|
|
Correspondent Contact |
MARK MIZERKIEWICZ |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/16/1996 |
Decision Date | 10/10/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|