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U.S. Department of Health and Human Services

Product Classification
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Device body temperature sensing software
Definition Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
Physical State Software
Technical Method Uses infrared sensor data to approximate human body temperature.
Target Area Software
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQZA
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.2915
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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