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FDA 510(k) Application Details - K173663
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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