MODEL SP5107 THERMODILUTION CATHETER

K810730 · Gould, Inc. · KRB · Mar 27, 1981 · Cardiovascular

Device Facts

Record IDK810730
Device NameMODEL SP5107 THERMODILUTION CATHETER
ApplicantGould, Inc.
Product CodeKRB · Cardiovascular
Decision DateMar 27, 1981
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1915
Device ClassClass 2

Regulatory Classification

Identification

A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

Innolitics

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