Device Classification Name |
oximeter
|
510(k) Number |
K080348 |
Device Name |
OXISCAN II DATA MANAGEMENT SYSTEM |
Applicant |
AIRSEP CORP. |
401 CREEKSIDE DR. |
BUFFALO,
NY
14228 -2085
|
|
Applicant Contact |
PETER WEISERBORN |
Correspondent |
AIRSEP CORP. |
401 CREEKSIDE DR. |
BUFFALO,
NY
14228 -2085
|
|
Correspondent Contact |
PETER WEISERBORN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/11/2008 |
Decision Date | 10/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|