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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K243598
Device Name Welch Allyn Connex® 360 (Multiple)
Applicant
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls,  NY  13153
Applicant Contact Susan Schmidt
Correspondent
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls,  NY  13153
Correspondent Contact Susan Schmidt
Subsequent Product Code
MWI  
Date Received11/21/2024
Decision Date 07/13/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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