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FDA 510(k) Application Details - K172221
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K172221
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
TaiDoc Technology Corporation
6F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City 24888 TW
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Contact
Anne Kuo
Other 510(k) Applications for this Contact
Regulation Number
870.2300
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Classification Product Code
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/24/2017
Decision Date
06/06/2018
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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