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510(k) K180880

DARI Health by Scientific Analytics, Inc. — Product Code LXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2019
Date Received
April 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interactive Rehabilitation Exercise Devices
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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