Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-29: IEC 60601-2-19 1996-10:, Amendment 1 - Medical electrical equipment Part 2: Particular requirements for safety of baby incubators. (General Plastic Surgery/General Hospital)
Date of Standard: 1996. |
| 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: |
| Include all infant incubators except transport incubators |
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| Processes Affected: |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5400 |
Incubator, Neonatal |
Class 2 |
FMZ |
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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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