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FDA 510(k) Application Details - K013484
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
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510(K) Number
K013484
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
STEREOTAXIS, INC.
4041 FOREST PARK BLVD.
ST. LOUIS, MO 63108 US
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PETER A TAKES
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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
10/19/2001
Decision Date
05/02/2002
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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