FDA 510(k)

SAVI Dual (TM) Migraine Therapy

K-Number: K230358 · 2023-05-16

Decision Date2023-05-16

Product CodeOKP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SAVI Dual (TM) Migraine Therapy is a medical device manufactured by Eneura, Inc.. It received FDA 510(k) clearance on 2023-05-16 under approval number K230358. The device is classified under product code OKP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAVI Dual (TM) Migraine Therapy?

SAVI Dual (TM) Migraine Therapy is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Eneura, Inc.. The 510(k) number is K230358.

When was SAVI Dual (TM) Migraine Therapy approved by the FDA?

SAVI Dual (TM) Migraine Therapy received FDA 510(k) clearance on 2023-05-16, under approval number K230358.

What company makes SAVI Dual (TM) Migraine Therapy?

SAVI Dual (TM) Migraine Therapy is manufactured by Eneura, Inc..

What is the FDA product code for SAVI Dual (TM) Migraine Therapy?

The FDA product code for SAVI Dual (TM) Migraine Therapy is OKP.

Related Clinical Trials

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Other Devices by Eneura, Inc.

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Related Devices (Code: OKP)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.