FDA 510(k) Application Details - K223531

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K223531
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki FI-00510 FI
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Contact Joel Kent
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 11/23/2022
Decision Date 04/06/2023
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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