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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K120774
Device Name ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
Original Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 -0220
Original Contact kevin crossen
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/14/2012
Decision Date 04/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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