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FDA 510(k) Application Details - K982470
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
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
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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