Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-237: IEC 80601-2-59 (First edition - 2008), Medical Electrical Equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM 1. (General Plastic Surgery/General Hospital)
Date of Standard: 2009. |
| 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 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: |
| Electronic Clinical Thermometer |
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| Processes Affected: |
| 510(k), PMA, IDE, PreIDE, 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 |
| §880.2910 |
Thermometer, Electronic, Clinical |
Class 2 |
FLL |
| §880.2910 |
Thermometer, Exhaled Breath |
Class 2 |
OZK |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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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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