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Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-235: AAMI / ANSI / IEC 60601-2-50:2009, medical electrical equipment - part 2-50: particular requirements for the basic safety and essential performance of infant phototherapy equipment. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
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
 
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Neonatal phototherapy unit
Processes Affected:
510(k), PreIDE, IDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5700 Unit, Neonatal Phototherapy Class 2 LBI
FDA Technical Contact:
 Sajjad Syed
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2525
  Silver Spring MD 20993
  301/796-6295
  email: sajjad.syed@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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