FDA 510(k) Application Details - K972199

Device Classification Name Electrocardiograph

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510(K) Number K972199
Device Name Electrocardiograph
Applicant MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact KRISTIN PABST
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 06/11/1997
Decision Date 09/25/1997
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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