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FDA 510(k) Application Details - K080112
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K080112
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
MED-DYNE
2775 SOUTH FLOYD ST.
LOUISVILLE, KY 40209 US
Other 510(k) Applications for this Company
Contact
E.W. JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/2008
Decision Date
06/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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