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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stethoscope, electronic
510(k) Number K173663
Device Name Electronic Stethoscope DS3011A
Applicant
IMEDIPLUS INC.
2F, 12, Shengyi Rd.Sec.2
chupei city,  TW 30261
Applicant Contact shirley lai
Correspondent
IMEDIPLUS INC.
2F, 12, Shengyi Rd.Sec.2
chupei city,  TW 30261
Correspondent Contact shirley lai
Regulation Number870.1875
Classification Product Code
DQD  
Date Received11/29/2017
Decision Date 08/17/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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