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510(k) K242345

Delphi Stimulator by Quantalx Neuroscience — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2024
Date Received
August 7, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Quantalx Neuroscience

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  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)

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