FDA 510(k)

Voluson S6, Voluson S8, Voluson S10

K-Number: K160184 · 2016-02-25

Decision Date2016-02-25

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Voluson S6, Voluson S8, Voluson S10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-02-25 under 510(k) 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. The listed applicant is GE Healthcare. The 510(k) number is K160184.

When did Voluson S6, Voluson S8, Voluson S10 receive FDA 510(k) clearance?

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

Who is the listed applicant for Voluson S6, Voluson S8, Voluson S10?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

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

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