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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 3-129: AAMI / ANSI EC53:2013, ecg trunk cables and patient leadwires. (Cardiovascular)

Date of Standard: 2013. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
CDRH Office and Division associated with recognized standards:
Devices Affected:
Electrode Leadwires and Patient Cables intended for use with the following devices: Electrocardiographs (ECGS), Cardiac Monitors, Arrhythmia Detectors and Alarms, DC Defibrillators, Multiparameter Physiological Monitors, Breathing Frequency Monitors, Ventilatory Effort Monitors (Apnea Detectors), Other devices that use patient cables
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§868.2375 Monitor, Breathing Frequency Class 2 BZQ
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
§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 Low Patient Acuity Monitoring System Class 2 PFY
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2300 Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2340 Single Lead Over-The-Counter Electrocardiograph Class 2 OEY
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
§870.2800 Electrocardiograph,Ambulatory(Without Analysis) Class 2 MWJ
§870.2800 Recorder, Magnetic Tape, Medical Class 2 DSH
§870.2910 Transmitters And Receivers, Physiological Signal, Radiofrequency Class 2 DRG
§870.5300 Atrial Defibrillator Class 3 MPC
§870.5300 Dc-Defibrillator, High Energy, (Including Paddles) Class 3 DRK
§870.5300 Dc-Defibrillator, Low-Energy, (Including Paddles) Class 2 LDD
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
§878.4040 Respirator,Surgical Class 2 MSH
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contacts:
 Jeff Silberberg
  10903 New Hampshire Avenue WO62 RM1216
  Silver Spring MD 20993
  email: jeffrey.silberberg@fda.hhs.gov
 Shawn Forrest
  10903 New Hampshire Avenue WO66, RM1326
  Silver Spring MD 20993
  email: shawn.forrest@fda.hhs.gov