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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Contact CLARK VIER
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Regulation Number 870.2360

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Classification Product Code DRX
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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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