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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 K061590
Device Name SMDIE DEVICE INTERFACING SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT
2454 MCMULLEN BOOTH ROAD
SUITE 427
CLEARWATER,  FL  33759
Applicant Contact IAN GORDON
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/08/2006
Decision Date 06/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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