FDA 510(k)

Elitone Device

K-Number: K183585 · 2019-02-11

Decision Date2019-02-11

Product CodeQAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Elitone Device is the device name listed in this FDA 510(k) record. The listed applicant is Elidah, Inc.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K183585. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elitone Device?

Elitone Device is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Elidah, Inc.. The 510(k) number is K183585.

When did Elitone Device receive FDA 510(k) clearance?

Elitone Device received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183585.

Who is the listed applicant for Elitone Device?

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

What is the FDA product code for Elitone Device?

The FDA product code for Elitone Device is QAJ.

Other records listing Elidah, 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.

K253285Elitone for Men K223884ELITONE Urge Urinary Incontinence Device

Related Devices (Code: QAJ)

K253285Elitone for MenElidah, Inc.K223884ELITONE Urge Urinary Incontinence DeviceElidah, Inc.K192357INNOVOAtlantic Therapeutics, Ltd.

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.