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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 K180685
Device Name AS-3XX Series Fingertip Pulse Oximeter
Applicant
Xiamen Acurio Instruments Co., Ltd
3rd-4th Floors, BI Park, No.2028
Wengjiao West Road, Haicang District
Xiamen,  CN 361026
Applicant Contact Angel Liu
Correspondent
Xiamen Acurio Instruments Co., Ltd
3rd-4th Floors, BI Park, No.2028
Wengjiao West Road, Haicang District
Xiamen,  CN 361026
Correspondent Contact Angel Liu
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/15/2018
Decision Date 11/29/2018
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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