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regulatory certification
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FDA
Our bioimpedance devices are registered by the FDA to assess changes
in electrical tissue conductivity in order to analyze body composition. Our
registration number is K874361.
Safety Tests
Safety tests have been performed on our analyzers in accordance with
applicable requirements of the Safety Standard for Medical Electrical
Equipment (i.e. IEC 601-1).
Our analyzers also meet the intent of Directive 89/336/EEC for
Electromagnetic Compatibility. Compliance was demonstrated with regard to
the following specifications as listed in the official Journal of the
European Communities:
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| EN 55011 Class A |
Radiated and Conducted Emissions |
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| EN 60601-1-2 (1993) |
Immunity |
| IEC 801-2 |
Electrostatic Discharge |
| IEC 801-3 |
Radiated Susceptibility |
| IEC 801-4 |
Electrical Fast Transient Burst |
| IEC 801-5 |
Surge |
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