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FDA 510(k)

Voluson S6, Voluson S8, Voluson S10

K-Number: K160184 · 2016-02-25

ApplicantGE Healthcare
Decision Date2016-02-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voluson S6, Voluson S8, Voluson S10 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-02-25 under approval number K160184. 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 S10?

Voluson S6, Voluson S8, Voluson S10 is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by GE Healthcare. The 510(k) number is K160184.

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

Voluson S6, Voluson S8, Voluson S10 received FDA 510(k) clearance on 2016-02-25, under approval number K160184.

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

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

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

The FDA product code for Voluson S6, Voluson S8, Voluson S10 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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