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510(k) K242326

Wave Electrode (AE02-60); Wave Electrode (AE02-50) by Bionit Labs Srl — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2025
Date Received
August 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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