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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

K-Number: K202979 · 2020-12-21

ApplicantLode B.V.
Decision Date2020-12-21
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Lode B.V.. The 510(k) number is K202979.

When was MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra approved by the FDA?

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 approval number K202979.

What company makes 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 manufactured by Lode B.V..

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.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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