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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 K160023
Device Name Electronic Stethoscope DS301
Applicant
IMEDIPLUS INC.
2F, 12, SHENGYI RD.SEC.2
chubei city,  TW 30261
Applicant Contact shirley lai
Correspondent
IMEDIPLUS INC.
2F, 12, SHENGYI RD.SEC.2
chubei city,  TW 30261
Correspondent Contact shirley lai
Regulation Number870.1875
Classification Product Code
DQD  
Date Received01/06/2016
Decision Date 09/30/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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