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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 K212473
Device Name Welch Allyn Connex Central Station
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Applicant Contact Megan Pellenz
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Correspondent Contact Megan Pellenz
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
MHX  
Date Received08/06/2021
Decision Date 10/28/2022
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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