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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K223382
Device Name AeviceMD
Applicant
Aevice Health Pte. , Ltd.
18 Howard Rd., #06-11 Novelty Bizcentre
Singapore,  SG 369585
Applicant Contact Adrian Ang
Correspondent
Aevice Health Pte. , Ltd.
18 Howard Rd., #06-11 Novelty Bizcentre
Singapore,  SG 369585
Correspondent Contact Adrian Ang
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DQD  
Date Received11/07/2022
Decision Date 07/07/2023
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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