21 C.F.R. § 870.1915
Thermodilution probe.
Cite as 21 C.F.R. § 870.1915 (2026)
(a) 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. (b) Classification. Class II (performance standards).