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FDA 510(k) Application Details - K212593
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
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510(K) Number
K212593
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
Biotronick, Inc.
6024 Jean Road
Lake Oswego, OR 97035 US
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Contact
Jon Brumbaugh
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Regulation Number
870.1220
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Classification Product Code
DRF
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More FDA Info for this Product Code
Date Received
08/16/2021
Decision Date
10/15/2021
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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