Comparison Study of Core Temperature Thermometry Systems

Deep Tissue Thermometry 510(k) Premarket Notification Trial

The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.

The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

Inclusion Criteria:

-

Exclusion Criteria:

• Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization