• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 032 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 13-52: IEEE / ISO 11073-10408 First edition 2010-05-01, health informatics - point-of-care medical device communication - part 10408: device specialization - thermometer. (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)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
Devices Affected:
Thermometers
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant Guidance:
Guidance on the Content of Premarket Nofication [510(k)] Submissions for Clinical Electronic Thermometers
FDA Technical Contact:
 Lening Shen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2558
  Silver Spring MD 20993
  301/796-6291
  email: lening.shen@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
-
-