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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 6-125
Standard
ASTM E1965-98 (Reapproved 2016)
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant FDA Guidance and/or Supportive Publications
Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Thermometers
FDA Technical Contact
 Robert Meyer
  FDA/OMPT/CTP/OS/DPS/
  240-402-1842
  Robert.Meyer@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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