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FDA 510(k) Application Details - K192593
Device Classification Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
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510(K) Number
K192593
Device Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant
Abbott
15900 Valley View Ct.
Sylmar, CA 91342 US
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Contact
Laura Sparks
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Regulation Number
870.2800
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Classification Product Code
MXC
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More FDA Info for this Product Code
Date Received
09/20/2019
Decision Date
10/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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