Health informatics - Personal health
13-55 Software
device communication Part 10421:
Std
Device specialization - Peak expiratory 11073-10421-2010
08/05/2013 IEEE
flow monitor (peak flow)
Recognition List Number: 032 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 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
Device Name
Device Product
Number
Class
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/Gui
danceDocuments/UCM81354.pdf
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR868.1860]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 868 -- ANESTHESIOLOGY DEVICES
Subpart B--Diagnostic Devices
Sec. 868.1860 Peak-flow meter for spirometry.
(a)Identification. A peak-flow meter for spirometry is a device used to
measure a patient's maximum ventilatory flow rate.
(b)Classification. Class II (performance standards).