FDA 510(k) Application Details - K022537

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

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510(K) Number K022537
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant COLIN MEDICAL INSTRUMENTS CORP.
5850 FARINON DR.
SAN ANTONIO, TX 78249 US
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Contact MARK RISON
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 08/01/2002
Decision Date 09/13/2002
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 Y
Expedited Review



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