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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
Original Applicant
AIRSEP CORP.
401 creekside dr.
buffalo,  NY  14228 2085
Original Contact peter weiserborn
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/14/2008
Decision Date 10/09/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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