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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
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