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FDA 510(k) Application Details - K220795
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K220795
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
QT Medical, Inc.
1360 Valley Vista Drive, Suite 203
Diamond Bar, CA 91765 US
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Contact
Jackal Chen
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Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
03/18/2022
Decision Date
09/26/2022
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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