Trials / Completed
CompletedNCT01255865
Comparison Study of Core Temperature Thermometry Systems
Deep Tissue Thermometry 510(k) Premarket Notification Trial
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 111 (actual)
- Sponsor
- 3M · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.
Detailed description
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.
Conditions
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-08-01
- Completion
- 2011-12-01
- First posted
- 2010-12-08
- Last updated
- 2020-08-25
- Results posted
- 2020-08-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01255865. Inclusion in this directory is not an endorsement.