Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 019 Publication Date: 12/19/2007 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-200: ASTM E1061 -01 (Reapproved 2007), Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers. (General Plastic Surgery/General Hospital)

Date of Standard: 2007. 
Address of Standards Organization:
  ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Forehead Thermometers
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§880.2200 Strip, Temperature, Forehead, Liquid Crystal Class 2 KPD
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  William Burdick
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2522
  Silver Spring MD 20993
  301/796-6286
  Email: william.burdick@fda.hhs.gov
-
-