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