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FDA 510(k)

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

N.º K: K202979 · 2020-12-21

SolicitanteLode B.V.
Fecha de decisión2020-12-21
Código de productoISD
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Lode B.V.. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K202979. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra?

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is Lode B.V.. The 510(k) number is K202979.

When did MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra receive FDA 510(k) clearance?

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra received FDA 510(k) clearance on 2020-12-21, under 510(k) number K202979.

Who is the listed applicant for MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra?

The FDA 510(k) record lists Lode B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra?

The FDA product code for MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra is ISD.

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Dispositivos relacionados (Código: ISD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

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