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FDA 510(k) Application Details - K050248
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K050248
Device Name
Electrode, Electrocardiograph
Applicant
ELECTRAMOLD
3600 CHAMBERLAIN LANE
SUITE 356
LOUISVILLE, KY 40241-1914 US
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Contact
E.W. JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
870.2360
More FDA Info for this Regulation Number
Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/03/2005
Decision Date
05/25/2005
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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