FDA 510(k) Application Details - K113054

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

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510(K) Number K113054
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant HIDALGO LIMITED
Unit F Buckinghamway Business Park
Anderson Rd, Swavesey
Cambridge CB24 4UQ GB
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Contact EKTA SOOD
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 10/13/2011
Decision Date 02/17/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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