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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, electrode recording, or probe, electrode recording
510(k) Number K915159
Device Name PEDIATRIC MULTI-FUNCTION ELECTRODES
Applicant
ZMI CORP.
500 WEST CUMMINGS PARK
WOBURN,  MA  01801
Applicant Contact ROD BOUCHER
Correspondent
ZMI CORP.
500 WEST CUMMINGS PARK
WOBURN,  MA  01801
Correspondent Contact ROD BOUCHER
Regulation Number870.1220
Classification Product Code
DRF  
Date Received11/14/1991
Decision Date 02/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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