FDA 510(k)

Relivion

K-Number: K212106 · 2021-08-02

Decision Date2021-08-02

Product CodePCC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Relivion is the device name listed in this FDA 510(k) record. The listed applicant is Neurolief , Ltd.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K212106. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Relivion?

Relivion is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Neurolief , Ltd.. The 510(k) number is K212106.

When did Relivion receive FDA 510(k) clearance?

Relivion received FDA 510(k) clearance on 2021-08-02, under 510(k) number K212106.

Who is the listed applicant for Relivion?

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

What is the FDA product code for Relivion?

The FDA product code for Relivion is PCC.

Other records listing Neurolief , Ltd. 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.

PMA P250010Cranial electrotherapy stimulator to treat depression K203419Relivion

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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.