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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 13-55: IEEE Std 11073-10421-2010, health informatics - personal health device communication part 10421: device specialization - peak expiratory flow monitor (peak flow). (Software/Informatics)

Date of Standard: 2010. 
Address of Standards Development Organization:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Peak Flow Meter for Spirometry
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard with the following execeptions: *Page 1, Section 1.1 Scope: The entire second paragraph is not recognized. *Page 3, Section 3.1 Definitions: The following definitions are not recognized: -Forced expiratory volume -Peak expiratory flow rate -Peak expiratory flow monitor -Personal best peak expiratory flow -Predicted average peak expiratory flow
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.1860 Meter, Peak Flow, Spirometry Class 2 BZH
Relevant Guidance:
Guidance for Labeling Peak Flow Meters for Over the Counter Sale, Version 1.0, 1993.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM81354.pdf
FDA Technical Contact:
 Mario Mendoza
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 4212
  Silver Spring MD 20993
  240/402-5121
  email: mario.mendoza@fda.hhs.gov
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