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Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 1-87: IEC 60601-2-23 Edition 3.0 2011-02, medical electrical equipment - part 2-23: particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. (Anesthesias)

Date of Standard: 2011. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Transcutaneous oxygen and carbon dioxide partial pressure monitors
Processes Affected:
510(k), PMA, ID,E PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard and its annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.2480 Monitor, Carbon-Dioxide, Cutaneous Class 2 LKD
§868.2500 Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Class 2 KLK
§868.2500 Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia Class 2 LPP
Relevant Guidance:
Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA
FDA Technical Contact:
 Neel Patel
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2532
  Silver Spring MD 20993
  301/796-6274
  email: neel.patel@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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