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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 K030419
Device Name VITERION 100 TELEHEALTH MONITOR
Applicant
VITERION TELEHEALTHCARE LLC
555 WHITE PLAINS RD.
TARRYTOWN,  NY  10591
Applicant Contact THUY NGUYEN
Correspondent
VITERION TELEHEALTHCARE LLC
555 WHITE PLAINS RD.
TARRYTOWN,  NY  10591
Correspondent Contact THUY NGUYEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/10/2003
Decision Date 11/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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