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 the device name listed in this FDA 510(k) record. The listed applicant is Eneura, Inc.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) 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. The listed applicant is Eneura, Inc.. The 510(k) number is K230358.

When did SAVI Dual (TM) Migraine Therapy receive FDA 510(k) clearance?

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

Who is the listed applicant for SAVI Dual (TM) Migraine Therapy?

The FDA 510(k) record lists Eneura, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Eneura, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182976SpringTMS K162797SpringTMS K161663sTMS mini

Related Devices (Code: OKP)

K182976SpringTMSEneura®, Inc.K162797SpringTMSEneura, Inc.K161663sTMS miniEneura, Inc.

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.