Name: Predicase
Price: 199 USD

K-number	K202979
Device name	MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
Applicant	Lode B.V.
Product code	ISD
Device class	Class II
Decision date	Dec 21, 2020
Decision	Substantially Equivalent
Regulation	890.5360

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.