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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 025 FR Publication Date: 10/04/2010 

Part B: Supplementary Information

Recognition Number 6-125: ASTM E1965-98 (Reapproved 2009), standard specification for infrared thermometers for intermittent determination of patient temperature. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
(3)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(4)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Infra red ear & surface thermometers
Processes Affected:
510(k), PMA, PreIDE, GMP, PDP, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant Guidance:
Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Thermometers
FDA Technical Contact:
 William Burdick
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2522
  Silver Spring MD 20993
  301/796-6286
  email: william.burdick@fda.hhs.gov
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