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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 6-300: IEC 60601-2-21 Edition 2.0 2009-02, medical electrical equipment - part 2-21: particular requirements for the basic safety and essential performance of infant radiant warmers. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Infant Radiant Warmers
Processes Affected:
510(k), PMA, 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
§880.5130 Warmer, Infant Radiant Class 2 FMT
FDA Technical Contact:
 Nancy Pressly
  FDA/CDRH/OSB
  10903 New Hampshire Avenue Building 66, Room 3204
  Silver Spring MD 20993
  301/796-5437
  email: nancy.pressly@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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