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510(k) K212957

BioButton System by Biolntellisense, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2022
Date Received
September 16, 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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