Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-279: IEC 60601-2-19 (Second edition - 2009), Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1. (General Plastic Surgery/General Hospital)
Date of Standard: 2012. |
| 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: |
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| Processes Affected: |
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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 |
| §880.5410 |
Incubator, Neonatal Transport |
Class 2 |
FPL |
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| Relevant Guidance: |
| Guidance for Industry and FDA Reviewers/Staff Neonatal and Neonatal Transport Incubators - Premarket Notifications Document issued on: September 18, 1998 |
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| FDA Technical Contact: |
| William Burdick |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2522 |
| Silver Spring MD 20993 |
| 301/796-6286 |
| Email: william.burdick@fda.hhs.gov |
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