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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 K241411
Device Name Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Applicant Contact Beth Rice
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
Skaneateles Falls,  NY  13153
Correspondent Contact Beth Rice
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   DQA   DXN   FLL  
Date Received05/17/2024
Decision Date 12/20/2024
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
Recalls CDRH Recalls
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