Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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3-118
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Standard | |
ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
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Scope/AbstractThis recommended practice establishes a method for testing and reporting the performance of algorithms used to detect cardiac rhythm disturbances, including the ST segment. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§870.1025 |
Detector And Alarm, Arrhythmia |
Class 2 |
DSI |
§870.1025 |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
Class 2 |
MHX |
§870.1025 |
Monitor, St Segment With Alarm |
Class 2 |
MLD |
§870.2300 |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
Class 2 |
DRT |
§870.2340 |
Electrocardiograph |
Class 2 |
DPS |
§870.2340 |
Monitor, St Segment |
Class 2 |
MLC |
§870.2800 |
Electrocardiograph, Ambulatory, With Analysis Algorithm |
Class 2 |
MLO |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, Issued October 2003. |
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FDA Technical Contact
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |