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FDA 510(k) Application Details - K172778
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K172778
Device Name
Electrocardiograph
Applicant
DailyCare Biomedical, Inc
7f, No. 1, Ding-An Rd, Zhongli Dist.
Taoyuan City Taoyuan 320 TW
Other 510(k) Applications for this Company
Contact
Ming Da Lee
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2017
Decision Date
07/05/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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