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510(k) K243746

Delphi Amplifier by Quantalx Neroscience — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2025
Date Received
December 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

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