FDA 510(k) Application Details - K033988

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

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510(K) Number K033988
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant GOLDWAY (US), INC.
2600 MISSION STREET
SUITE 100
SAN MARINO, CA 91108 US
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Contact YINGCHAO XIAO
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 12/23/2003
Decision Date 02/25/2004
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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