Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-235: AAMI / ANSI / IEC 60601-2-50:2009, Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment. (General Plastic Surgery/General Hospital)
Date of Standard: 2009. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| 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 Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| (3) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
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| Devices Affected: |
| Neonatal phototherapy unit |
|
| Processes Affected: |
| 510(k), PreIDE, IDE, HDE, GMP, Design Controls |
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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 |
| §880.5700 |
Unit, Neonatal Phototherapy |
Class 2 |
LBI |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Charles Zimliki |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2556 |
| Silver Spring MD 20993 |
| 301/796-6297 |
| Email: charles.zimliki@fda.hhs.gov |
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