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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 K153335
Device Name AlertWatch: OR
Applicant
ALERTWATCH LLC
1600 HURON PARKWAY, BLDG. 520, STE. 2326
ANN ARBOR,  MI  48109
Applicant Contact Justin Adams
Correspondent
BIOLOGICS CONSULTING GROUP, INC.
400 N. WASHINGTON STREET
SUITE 100
ALEXANDRIA,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/19/2015
Decision Date 03/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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