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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
Model 020XXXX (WHERE XXXX= VARIOUS CONFIG), MOBILE ACUITY AKA MOBILE LT
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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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