Electronic Stethoscope DS3011A

Stethoscope, Electronic

IMEDIPLUS INC.

The following data is part of a premarket notification filed by Imediplus Inc. with the FDA for Electronic Stethoscope Ds3011a.

Pre-market Notification Details

Device IDK173663
510k NumberK173663
Device Name:Electronic Stethoscope DS3011A
ClassificationStethoscope, Electronic
Applicant IMEDIPLUS INC. 2F, 12, Shengyi Rd.Sec.2 Chupei City,  TW 30261
ContactShirley Lai
CorrespondentShirley Lai
IMEDIPLUS INC. 2F, 12, Shengyi Rd.Sec.2 Chupei City,  TW 30261
Product CodeDQD  
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-29
Decision Date2018-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719874400040 K173663 000

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