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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K070204
Device Name LINK TO ACUITY CLINICIAN NOTIFIER
Applicant
Welch Allyn Protocol, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact JEFFREY WAGNER
Correspondent
Welch Allyn Protocol, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact JEFFREY WAGNER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received01/22/2007
Decision Date 03/23/2007
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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