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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 12-247: ISO 11990-1 First edition 2011-08-01, lasers and laser-related equipment - determination of laser resistance of tracheal tubes - part 1: tracheal tube shaft. (Radiology)

Date of Standard: 2011. 
Address of Standards Development Organization:
 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:
Tracheal Tubes Claiming Laser Resistance
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5730 Changer, Tube, Endotracheal Class 2 LNZ
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5730 Tube, Tracheal, Reprocessed Class 2 NMA
§868.5740 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class 2 CBI
FDA Technical Contact:
 Robert James
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1216
  Silver Spring MD 20993
  301/796-2487
  email: robert.james@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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