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510(k) K900317

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER by Elecath — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
January 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

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