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FDA 510(k) Application Details - K060661
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K060661
Device Name
Electrode, Electrocardiograph
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact
KAREN RUSSELL
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
03/13/2006
Decision Date
04/07/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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