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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 a medical device manufactured by GN Hearing A/S. It received FDA 510(k) clearance on 2022-01-19 under approval 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. It is manufactured by GN Hearing A/S. The 510(k) number is K213424.

When was Jabra Enhance Plus approved by the FDA?

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

What company makes Jabra Enhance Plus?

Jabra Enhance Plus is manufactured by GN Hearing A/S.

What is the FDA product code for Jabra Enhance Plus?

The FDA product code for Jabra Enhance Plus is QDD.

Other Devices by GN Hearing A/S

K180495Tinnitus Sound Generator Module K181586Tinnitus Sound Generator Module K193303Tinnitus Sound Generator Module

Related Devices (Code: QDD)

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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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