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Recognition List Number: 032 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 13-54: IEEE / ISO 11073-10404 First edition 2010-05-01, health informatics - personal health device communication - part 10404: device specialization - pulse oximeter. (Software/Informatics)

Date of Standard: 2010. 
Addresses of Standards Development Organizations:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Pulse oximeters, ear oximeters, reprocessed pulse oximeters
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exception: Definition of "Spot-Check" in Clause 5.3.2.2 is not recognized.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2700 Oximeter Class 2 DQA
§870.2700 Oximeter, Reprocessed Class 2 NLF
§870.2710 Oximeter, Ear Class 2 DPZ
Relevant Guidance:
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm341718.htm

ISO 80601-2-61 First edition 2011-04-01, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
FDA Technical Contacts:
 Neel Patel
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2532
  Silver Spring MD 20993
  301/796-6274
  email: neel.patel@fda.hhs.gov
 Sandy Weininger
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 4212
  Silver Spring MD 20993
  301/796-2582
  email: sandy.weininger@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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