RANGE OF MOTION SENSOR, MODEL RM001

Goniometer, Ac-powered

NK BIOTECHNICAL ENGINEERING CO.

The following data is part of a premarket notification filed by Nk Biotechnical Engineering Co. with the FDA for Range Of Motion Sensor, Model Rm001.

Pre-market Notification Details

Device IDK914060
510k NumberK914060
Device Name:RANGE OF MOTION SENSOR, MODEL RM001
ClassificationGoniometer, Ac-powered
Applicant NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis,  MN  55426
ContactKaren Gotfredson
CorrespondentKaren Gotfredson
NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis,  MN  55426
Product CodeKQX  
CFR Regulation Number888.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-10
Decision Date1991-12-09

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