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FDA 510(k) Application Details - K980806
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K980806
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
AFFINITY MEDICAL TECHNOLOGIES, LLC.
17332 VON KARMAN AVE., #115
IRVINE, CA 92614 US
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Contact
MARY F PHILLIPP
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
03/03/1998
Decision Date
03/25/1998
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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