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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 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.

Study Status: Enrolling by invitation


Condition Intervention Phase
Thermometry Device Comparisons n/a N/A

Verified by Arizant Healthcare June, 2011

Sponsored by: Arizant Healthcare
Information provided by: Arizant Healthcare identifier: NCT01255865

Study Type: Interventional

Study Design: Observational Model: Case-Crossover

Cleveland Clinic
Cleveland, Ohio 44195
United States


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