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FDA 510(k) Application Details - K955815
Device Classification Name
Electrode, Electrocardiograph
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510(K) Number
K955815
Device Name
Electrode, Electrocardiograph
Applicant
CMC SENSE-IT, INC.
810 SOUTH 1ST. ST. #120
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
12/26/1995
Decision Date
07/23/1996
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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