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FDA 510(k) Application Details - K082851
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K082851
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNOVATION DR.
RP-2122
WAUWATOSA, WI 53226 US
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Contact
MATTHIAS BUERGER
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
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More FDA Info for this Product Code
Date Received
09/29/2008
Decision Date
11/19/2008
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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