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510(k) K211365

Alio Medical Remote Monitoring System by Graftworx, Inc. Dba Alio — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2022
Date Received
May 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

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