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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR 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 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:
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
§870.2060 Amplifier And Signal Conditioner, Transducer Signal Class 2 DRQ
§870.2850 Transducer, Blood-Pressure, Extravascular Class 2 DRS
§870.2870 Transducer, Pressure, Catheter Tip Class 2 DXO
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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