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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(With Arrhythmia Detection Or Alarms)
510(k) Number K171621
Device Name Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
Applicant
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls,  NY  13153
Applicant Contact Mark Alsberge
Correspondent
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls,  NY  13153
Correspondent Contact Mark Alsberge
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Code
MWI  
Date Received06/02/2017
Decision Date 06/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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