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FDA 510(k) Application Details - K200722
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
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510(K) Number
K200722
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
QT Medical, Inc.
1360 Valley Vista Dr., Suite 203
Diamond Bar, CA 91765 US
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Contact
Ruey-Kang Chang
Other 510(k) Applications for this Contact
Regulation Number
870.2900
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Classification Product Code
DSA
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More FDA Info for this Product Code
Date Received
03/19/2020
Decision Date
06/03/2021
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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