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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K843412
Device Name FLOW DIRECTED THERMODILUTION CATH W/VEN
Applicant
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact ROBERT TETU
Correspondent
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact ROBERT TETU
Regulation Number870.1915
Classification Product Code
KRB  
Date Received08/31/1984
Decision Date 11/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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