FDA 510(k) Application Details - K041376

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

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510(K) Number K041376
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY, MA 01960 US
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Contact DONALD J SHERRATT
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 05/24/2004
Decision Date 07/20/2004
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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