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

Part B: Supplementary Information

Recognition Number 6-230: AAMI / ANSI / IEC 60601-2-19:2009, medical electrical equipment - part 2-19: particular requirements for the basic safety and essential performance of infant incubators. (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
CDRH Office and Division associated with recognized standards:
Devices Affected:
Include all infant incubators except transport incubators
Processes Affected:
510(k), PMA, IDE, PreIDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
§880.5400 Incubator, Neonatal Class 2 FMZ
Relevant Guidance:
Guidance for Industry and FDA Reviewers/Staff Neonatal and Neonatal Transport Incubators - Premarket Notifications Document issued on: September 18, 1998
FDA Technical Contacts:
 Crystal Lewis
  10903 New Hampshire Ave WO66 RM2628
  Silver Spring MD 20993
  email: Crystal.Lewis@fda.hhs.gov
 Carolyn Cochenour
  10903 New Hampshire Ave WO66 RM2546
  Silver Spring MD 20993
  email: Carolyn.Cochenour@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