FDA 510(k) Application Details - K023195

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

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510(K) Number K023195
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant SCHILLER MEDICAL S.A.
4 RUE LOUIS PASTEUR
ZAE SUD BP 90050
WISSEMBOURG CEDEX 67162 FR
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Contact COURT GOEHRY
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 09/25/2002
Decision Date 06/03/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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