Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-6: IEC 60601-2-36 (1997), 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 Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Extracorporeal Shockwave Lithotripters |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5990 |
Lithotriptor, Extracorporeal Shock-Wave,Urological |
Class 2 |
LNS |
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| 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 |
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| FDA Technical Contact: |
| Gerald Harris |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2104 |
| Silver Spring MD 20993 |
| 301/796-2508 |
| Email: gerald.harris@fda.hhs.gov |
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