FDA 510(k) Application Details - K202336

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

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510(K) Number K202336
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District Pingshan District
Shenzhen 518122 CN
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Contact Alice Yang
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 08/17/2020
Decision Date 01/23/2021
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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