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FDA 510(k) Application Details - K963159
Device Classification Name
Electrode, Electrocardiograph
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510(K) Number
K963159
Device Name
Electrode, Electrocardiograph
Applicant
CMC SENSE-IT, INC.
810 SOUTH 1ST STREET, #120
P.O. BOX 691143
HOPKINS, MN 55343 US
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CLARK VIER
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Regulation Number
870.2360
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Classification Product Code
DRX
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More FDA Info for this Product Code
Date Received
08/14/1996
Decision Date
12/11/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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