FDA 510(k) Application Details - K170995

Device Classification Name Electrocardiograph

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510(K) Number K170995
Device Name Electrocardiograph
Applicant Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District
Shenzhen 518122 CN
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Contact Alice Yang
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 04/03/2017
Decision Date 06/02/2017
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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