Product Classification

• Device: thermometer, electronic, clinical
• Regulation Description: Clinical electronic thermometer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FLL
• Submission Type: 510(k)
• Regulation Number: 880.2910
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 80601-2-56 First Edition 2009-10-01 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
• ASTM E1104-98 (Reapproved 2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
• ASTM E1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
• ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• IEC 80601-2-59 (First edition - 2008) Medical Electrical Equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM 1

Guidance Document

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.