FDA 510(k) Application Details - K042981

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

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510(K) Number K042981
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant BIOLOGICAL SIGNAL PROCESSING LTD.
20 HATA'AS ST
KFAR SABA 44425 IL
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Contact ARAVA HACOHEN
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 10/29/2004
Decision Date 03/10/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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