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FDA 510(k)

Jabra Enhance Select Self-fit (Jabra Enhance Select 550)

K-Number: K254108 · 2026-06-25

Decision Date2026-06-25
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Jabra Enhance Select Self-fit (Jabra Enhance Select 550) is the device name listed in this FDA 510(k) record. The listed applicant is GN Hearing A/S. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K254108. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jabra Enhance Select Self-fit (Jabra Enhance Select 550)?

Jabra Enhance Select Self-fit (Jabra Enhance Select 550) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is GN Hearing A/S. The 510(k) number is K254108.

When did Jabra Enhance Select Self-fit (Jabra Enhance Select 550) receive FDA 510(k) clearance?

Jabra Enhance Select Self-fit (Jabra Enhance Select 550) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K254108.

Who is the listed applicant for Jabra Enhance Select Self-fit (Jabra Enhance Select 550)?

The FDA 510(k) record lists GN Hearing A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jabra Enhance Select Self-fit (Jabra Enhance Select 550)?

The FDA product code for Jabra Enhance Select Self-fit (Jabra Enhance Select 550) is QUH.

Other records listing GN Hearing A/S 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.

Related Devices (Code: QUH)

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.

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.