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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(With Arrhythmia Detection Or Alarms)
510(k) Number K232962
Device Name Patient Monitor (iX10, iX12, iX15)
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 Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CBQ   CBR   CBS   CCK  
CCL   DPS   DQA   DRT   DSI   DSK  
DXN   FLL   MLD   NHO   NHP   NHQ  
Date Received09/21/2023
Decision Date 04/19/2024
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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