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FDA 510(k)

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

K-Number: K213642 · 2022-01-13

ApplicantGE Healthcare
Decision Date2022-01-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2022-01-13 under approval number K213642. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is a medical device that received FDA 510(k) clearance on 2022-01-13. It is manufactured by GE Healthcare. The 510(k) number is K213642.

When was Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert approved by the FDA?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert received FDA 510(k) clearance on 2022-01-13, under approval number K213642.

What company makes Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is manufactured by GE Healthcare.

What is the FDA product code for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

The FDA product code for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is IYN.

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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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