Recognition List Number: 020 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 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: |
| National, Vertical, Test Method & Device Specification |
| 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 Recommendations in the "Relevant Guidance" listed below are not superceded by this standard.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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