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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name exerciser, measuring
510(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.
Zernikepark 16
Groningen,  NL 9747 AN
Applicant Contact J.R. Fransens
Correspondent
Lode B.V.
Zernikepark 16
Groningen,  NL 9747 AN
Correspondent Contact J.R. Fransens
Regulation Number890.5360
Classification Product Code
ISD  
Date Received09/30/2020
Decision Date 12/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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