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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 K233963
Device Name Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
Applicant
Taiwan Aulisa Medical Devices Technologies, Inc.
6f-2, # 3-1, Yuanqu St., Nangang Dist.,
Taipei City,  TW 115
Applicant Contact Ming Hsiu Hsiao
Correspondent
Taiwan Aulisa Medical Devices Technologies, Inc.
6f-2, # 3-1, Yuanqu St., Nangang Dist.
Taipei City,  TW 115603
Correspondent Contact Derow Ma
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/15/2023
Decision Date 02/25/2025
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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