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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 6-177: ASTM E1112-00 (Reapproved 2011), standard specification for electronic thermometer for intermittent determination of patient temperature. (General Plastic Surgery/General Hospital)

Date of Standard: 2006. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
CDRH Office and Division associated with recognized standards:
Devices Affected:
Clinical Electronic thermometers including contact tympanic thermometers but exclude Infra red thermometers
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant Guidance:
Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Theromometers, Issued March 1993
FDA Technical Contact: