FDA 510(k) Application Details - K922927

Device Classification Name Electrocardiograph

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510(K) Number K922927
Device Name Electrocardiograph
Applicant MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE, WI US
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Contact LORI A DUMMER
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 06/17/1992
Decision Date 11/10/1992
Decision SE - Substantially Equivalent
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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