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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 9-6: IEC 60601-2-36 First edition 1997-03, medical electrical equipment - part 2-36: particular requirements for the safety of equipment for extracorporeally induced lithotripsy. (ObGyn/Gastroenterology)

Date of Standard: 1997. 
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:
Extracorporeal Shockwave Lithotripters
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.5990 Lithotriptor, Extracorporeal Shock-Wave,Urological Class 2 LNS
Relevant Guidance:
Guidance for Industry and for FDA Reviewers-Guidance for the Content of Premarket Notification [510(k)s] for Extracoporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi. Issued August 9, 2000
FDA Technical Contact:
 Subha Maruvada
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2222
  Silver Spring MD 20993
  301/796-2524
  email: subha.maruvada@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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