• 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
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. (Anesthesiology)

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
CDRH Office and Division associated with recognized standards:
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:
Device Name Device
§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
  10903 New Hampshire Avenue WO66 RM2532
  Silver Spring MD 20993
  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