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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 032 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 13-56: IEEE Std 11073-10406-2011, health informatics - personal health device communication part 10406: device specialization - basic electrocardiograph. (Software/Informatics)

Date of Standard: 2011. 
Address of Standards Development Organization:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
1-to 3-lead ECG monitoring devices
Processes Affected:
510(k)
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2300 Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2300 System,Network And Communication,Physiological Monitors Class 2 MSX
§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
Relevant Guidance:
Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement), November 5, 1998
FDA Technical Contact:
 Linda Ricci
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1246
  Silver Spring MD 20993
  301/796-6325
  email: linda.ricci@fda.hhs.gov
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