PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER— 510(k) K900317

Name: FDA 510(k) clearance K900317
Creator: U.S. Food and Drug Administration
Published: 1990-06-22

Substantially Equivalent

Elecath

FDA 510(k) clearance K900317 for PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER, Substantially Equivalent on 1990-06-22. Applicant: Elecath. Device class: 2.

Clearance details

Applicant: Elecath
Product code: Code KRB
Device class: Class 2
Regulation: 21 CFR 870.1915
Advisory panel: Cardiovascular
Date received: 1990-01-23
Decision date: 1990-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rahway, NJ, US

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