FDA 510(k) Application Details - K982470

Device Classification Name Electrode, Electrocardiograph

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510(K) Number K982470
Device Name Electrode, Electrocardiograph
Applicant TAPUZ MEDICAL TECHNOLOGY LTD.
117 AHUZAH ST.
RA'ANANNA 43373 IL
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Contact SHOSHANA FRIEDMAN
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Regulation Number 870.2360

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Classification Product Code DRX
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Date Received 07/16/1998
Decision Date 10/14/1998
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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