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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 3-42: AAMI / ANSI EC13:2002/(R)2007, cardiac monitors, heart rate meters, and alarms. (Cardiovascular)

Date of Standard: 2002. 
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:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
CARDIAC MONITORS, HEART RATE METERS AND ALARMS
Processes Affected:
510(K), IDE, PMA, PDP, HDE
Type of Standard:
 Test Method & Device Specification, National, Vertical
Extent of Recognition:
Complete Standard.

This standard includes design, testing, and labeling requirements. Recommendations in the "Relevant Guidance" listed below are not superceded by this standard.

NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12
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
Relevant Guidance:
Guidance for Industry -- Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) issued by Pacing Devices Branch (now assigned to the CEMB Branch) of CDRH/ODE/DCD on November 5, 1998
FDA Technical Contacts:
 Charles Ho, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1318
  Silver Spring MD 20993
  301/796-6320
  email: charles.ho@fda.hhs.gov
 James Cheng
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1326
  Silver Spring MD 20993
  301/796-6306
  email: james.cheng@fda.hhs.gov
 Frank Lacy
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1236
  Silver Spring MD 20993
  301/796-6321
  email: frank.lacy@fda.hhs.gov
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