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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 K900317
Device Name PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
Applicant
Elecath
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Applicant Contact LORRAINE MONTEMURRO
Correspondent
Elecath
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Correspondent Contact LORRAINE MONTEMURRO
Regulation Number870.1915
Classification Product Code
KRB  
Date Received01/23/1990
Decision Date 06/22/1990
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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