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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K250135
Device Name WAVE Clinical Platform (2.0.000)
Applicant
Baxter Healthcare Corp/ Excel Medical
7111 Fairway Dr., Suite 205
Palm Beach Gardens,  FL  33418
Applicant Contact Gena Wolfe
Correspondent
Baxter Healthcare Corp/ Excel Medical
7111 Fairway Dr., Suite 205
Palm Beach Gardens,  FL  33418
Correspondent Contact Gena Wolfe
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/17/2025
Decision Date 01/16/2026
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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