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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Evala Nerve Stimulator (EPNR002)

Manufacturer

Epineuron Technologies, Inc.

Date Cleared

2026-02-27

(106 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

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N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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