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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K251326
Device Name Respiration Rate algorithm
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Manthan Damani
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Manthan Damani
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/29/2025
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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