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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K153719
Device Name LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
Applicant
HONEYWELL HOMMED, LLC
3400 INTERTECH DR.
SUITE 200
BROOKFIELD,  WI  53045
Applicant Contact Greg Lillegard
Correspondent
SPECTRAMEDEX, LLC
3215 GOLD ROAD
DELAFIELD,  WI  53018
Correspondent Contact JOHN ZIOBRO
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
BZH   DPS   DQA   DXN   FLL  
FRI   GJS   NBW   NXB   OUG  
Date Received12/28/2015
Decision Date 06/03/2016
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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