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FDA 510(k) Application Details - K221856
Device Classification Name
Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
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510(K) Number
K221856
Device Name
Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
Applicant
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035 US
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Contact
Jon Brumbaugh
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Regulation Number
870.1025
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Classification Product Code
MXD
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More FDA Info for this Product Code
Date Received
06/27/2022
Decision Date
07/27/2022
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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