| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
034
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Date of Entry 01/30/2014
|
|
FR Recognition Number
|
3-118
|
| Standard | |
ANSI AAMI EC57:2012
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
|
Scope/Abstract| This recommended practice establishes a method for testing and reporting the performance of algorithms used to detect cardiac rhythm disturbances, including the ST segment. |
|
| Extent of Recognition
|
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 |
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organizations
|
| FDA Specialty Task Group (STG)
|
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| *These are provided as examples and others may be applicable. |
