FDA 510(k) Application Details - K043368

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K043368
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant VISUAL TELECOMMUNICATIONS NETWORK, INC.
8201 GREENSBORO DR., STE. 600
MCLEAN, VA 22102 US
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Contact ALLEN IZADPANAH
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 12/08/2004
Decision Date 02/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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