FDA 510(k) Application Details - K073094

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

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510(K) Number K073094
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant TELEMEDIC SYSTEMS LTD
10 BILLETFIELD
TAUNTON, SOMERSET TA1 3NN GB
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Contact GERALD L BUSS
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 11/01/2007
Decision Date 01/04/2008
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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