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U.S. Department of Health and Human Services

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

Part B: Supplementary Information

Recognition Number 1-96: ISO 80601-2-55 First edition 2011-12-15, medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors. (Anesthesiology)

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
CDRH Office and Division associated with recognized standards:
Devices Affected:
Respiratory gas monitor (RGM) - medical electrical equipment intended to measure that gas level(s) or partial pressure(s) in respiratory gases, for example, anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. The RGM consists of a complete monitor including accessories, sensor, and sampling tube (in the case of a diverting respiratory gas monitor) specified by the manufacturer
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Device Name Device
§868.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class 2 CCK
§868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 CBQ
§868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 CBS
§868.1690 Analyzer, Gas, Nitrogen, Gaseous-Phase Class 2 CCI
§868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 CBR
§868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 CCL
Relevant Guidance:
There is no relevant guidance developed at this time.
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