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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number870.2700
Classification Product Code
DQA  
Date Received02/11/2008
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
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