Vibe SF Self-Fitting Hearing Aid
K-Number: K220403 · 2022-08-12
ApplicantWsaud A/S
Decision Date2022-08-12
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Vibe SF Self-Fitting Hearing Aid is a medical device manufactured by Wsaud A/S. It received FDA 510(k) clearance on 2022-08-12 under approval number K220403. 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 Vibe SF Self-Fitting Hearing Aid?
Vibe SF Self-Fitting Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by Wsaud A/S. The 510(k) number is K220403.
When was Vibe SF Self-Fitting Hearing Aid approved by the FDA?
Vibe SF Self-Fitting Hearing Aid received FDA 510(k) clearance on 2022-08-12, under approval number K220403.
What company makes Vibe SF Self-Fitting Hearing Aid?
Vibe SF Self-Fitting Hearing Aid is manufactured by Wsaud A/S.
What is the FDA product code for Vibe SF Self-Fitting Hearing Aid?
The FDA product code for Vibe SF Self-Fitting Hearing Aid is 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.