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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K240305
Device Name ANNE Limb
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 Sarah Coughlin
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DRG   FLL  
Date Received02/02/2024
Decision Date 05/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05693168
Reviewed by Third Party No
Combination Product No
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