SAVI Dual (TM) Migraine Therapy— 510(k) K230358

Substantially Equivalent

Eneura, Inc.

FDA 510(k) clearance K230358 for SAVI Dual (TM) Migraine Therapy, Substantially Equivalent on 2023-05-16. Applicant: Eneura, Inc.. Device class: 2.

Clearance details

Applicant: Eneura, Inc.
Product code: Code OKP
Device class: Class 2
Regulation: 21 CFR 882.5808
Advisory panel: Neurology
Date received: 2023-02-10
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.