FDA 510(k) Application Details - K020197

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

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510(K) Number K020197
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant CAPSULE TECHNOLOGIE
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 01/22/2002
Decision Date 02/21/2002
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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