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510(k) K260453

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) by Bionit Labs Srl — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
February 11, 2026
Clearance Type
Special
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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