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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 K121013
Device Name CONNEX VITAL SIGNS MONITOR 6000 SERIES
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact KEVIN CROSSEN
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact KEVIN CROSSEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/03/2012
Decision Date 07/26/2012
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
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