|Recognition List Number: 020 FR Publication Date: 09/09/2008
Part B: Supplementary Information
Recognition Number 3-65: AAMI / ANSI EC38:2007, medical electrical equipment - part 2-47: particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular)
Date of Standard: 2007.
|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) |
|Processes Affected: |
|510(k), PMA, IDE, PDP, HDE, Quality System Regulation|
|Type of Standard:|
| Test Method & Device Specification, National, Vertical|
|Extent of Recognition:|
|Complete Standard (except as noted below).|
Clause 22.214.171.124, System noise, is not recognized.
Clause 126.96.36.199, Overall system error, is not recognized.
Clause 188.8.131.52, Overall system error, is not recognized.
NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12.
There is a typographical error in clause 184.108.40.206, Figure 1. The 2 in the unit (G2Hz) should be a subscript.
|Related CFR Citations and Product Codes:|
||Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
||Electrocardiograph, Ambulatory, With Analysis Algorithm
|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: firstname.lastname@example.org||
| Benjamin C. Eloff, Ph.D |
| FDA/CDRH/ODE |
| 9200 Corporate Blvd., HFZ-450 |
| Rockville MD 20850 |
| 240/276-4058 |
| email: email@example.com|