Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-44: AAMI / ANSI BP22:1994 (R) 2011, Blood pressure transducers. (Cardiovascular)
Date of Standard: 1994. |
| 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: |
| Blood pressure transducers |
|
| Processes Affected: |
| 510(K), IDE, PMA, PDP, HDE, Quality System Regulation |
|
| Type of Standard: |
| National, Vertical, Test Methods |
| Extent of Recognition: |
Complete Standard and any annexes.
NOTE: A previous version of the BP22 standard had a typographical error in the equation for the overshoot Mo in clause 5.2.2.4.h. In BP22:2011, this error has been corrected. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.1110 |
Computer, Blood-Pressure |
Class 2 |
DSK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2060 |
Amplifier And Signal Conditioner, Transducer Signal |
Class 2 |
DRQ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2850 |
Transducer, Blood-Pressure, Extravascular |
Class 2 |
DRS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2870 |
Transducer, Pressure, Catheter Tip |
Class 2 |
DXO |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| 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 |
|
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