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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K242842
Device Name ANNE View, Central Hub
Applicant
Sibel Health, Inc.
2017 N Mendell St. Suite 2se
Chicago,  IL  60614
Applicant Contact Sarah Coughlin
Correspondent
Sibel Health, Inc.
2017 N Mendell St. Suite 2se
Chicago,  IL  60614
Correspondent Contact Peter Xu
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
DRG   KMI   MWI  
Date Received09/19/2024
Decision Date 01/08/2025
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
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