Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-41: AAMI / ANSI EC11:1991/(R)2007, Diagnostic electrocardiographic devices. (Cardiovascular)
Date of Standard: 2007. |
| 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: |
| ELECTROCARDIOGRAPHIC (ECG) SYSTEMS WITH DIRECT WRITING DEVICES |
|
| Processes Affected: |
| 510(K), IDE, PMA, PDP, HDE |
|
| Type of Standard: |
| National, Vertical, Test Method & Device Specification |
| Extent of Recognition: |
Complete Standard, except the following:
Method D of clause 3.2.7.2 Frequency and impulse response is not recognized.
Method D of clause 4.2.7.2 Frequency and impulse response is not recognized.
This standard includes design, testing, and labeling requirements. Recommendations in the "Relevant Guidance" listed below are not superseded by this standard.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 |
| §870.2340 |
Electrocardiograph |
Class 2 |
DPS |
| |
|
| Relevant Guidance: |
| Guidance for Industry -- Diagnostic ECG Guidance (including Non-Alarming ST Segment Measurement) 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 |
|
|
