FDA 510(k) Application Details - K102579

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

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510(K) Number K102579
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant BIOLOGICAL SIGNAL PROCESSING LTD.
291 Hillside Avenue
Somerset, MA 02726 US
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Contact GEORGE J HATTUB
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 09/08/2010
Decision Date 12/02/2010
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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