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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K233038
Device Name Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Applicant
Edan Instruments, Inc.
#15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen,  CN 518122
Applicant Contact Tracy Yue
Correspondent
Edan Instruments, Inc.
#15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Tracy Yue
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received09/25/2023
Decision Date 03/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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