FDA 510(k) Application Details - K173663

Device Classification Name Stethoscope, Electronic

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510(K) Number K173663
Device Name Stethoscope, Electronic
Applicant IMEDIPLUS INC.
2F, 12, Shengyi Rd.Sec.2
Chupei City 30261 TW
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Contact Shirley Lai
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 11/29/2017
Decision Date 08/17/2018
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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