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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
Predetermined Change
Control Plan Authorized		 No
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