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FDA 510(k)

Jabra Enhance Plus

K-Number: K213424 · 2022-01-19

ApplicantGN Hearing A/S
Decision Date2022-01-19
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Jabra Enhance Plus 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 2022-01-19 under 510(k) number K213424. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jabra Enhance Plus?

Jabra Enhance Plus is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is GN Hearing A/S. The 510(k) number is K213424.

When did Jabra Enhance Plus receive FDA 510(k) clearance?

Jabra Enhance Plus received FDA 510(k) clearance on 2022-01-19, under 510(k) number K213424.

Who is the listed applicant for Jabra Enhance Plus?

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 Plus?

The FDA product code for Jabra Enhance Plus is QDD.

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.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)K193303Tinnitus Sound Generator ModuleK180495Tinnitus Sound Generator ModuleK181586Tinnitus Sound Generator Module

Related Devices (Code: QDD)

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.

K223911Lumen 155-SFIntricon CorporationK220403Vibe SF Self-Fitting Hearing AidWsaud A/SK220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaidK212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy CompanyK211008Bose SoundControl Hearing AidsBose Corporation

Official Source

View on FDA Database →

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

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