Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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028
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Date of Entry 03/16/2012
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FR Recognition Number
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6-177
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Standard | |
ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
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Scope/Abstract1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. 1.2 This specification does not cover infrared thermometers. Specification E1965 covers specifications for IR thermometers. 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.2910 |
Thermometer, Electronic, Clinical
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Class 2
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FLL
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Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Theromometers, Issued March 1993
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |